Trial Outcomes & Findings for Cabozantinib S-Malate in Treating Patients With Advanced Solid Tumors and Human Immunodeficiency Virus (NCT NCT01822522)

NCT ID: NCT01822522

Last Updated: 2023-01-10

Results Overview

Will be reported using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The number of participant who experienced an adverse event

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 36 participants
• Primary outcome timeframe: Up to 30 days after completion of study treatment. Study treatment was between 1 and 82 weeks.
• Results posted on: 2023-01-10

Participant Flow

Participant milestones

Measure	Stratum A - 20 mg/Day Patients taking either ritonavir-boosted or cobicistat-boosted antiretroviral regimens Patients receive cabozantinib s-malate 20 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cabozantinib S-malate: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies	Stratum A - 40 mg/Day Patients taking either ritonavir-boosted or cobicistat-boosted antiretroviral regimens Patients receive cabozantinib s-malate 40 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cabozantinib S-malate: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies	Stratum A - 60 mg/Day Patients taking either ritonavir-boosted or cobicistat-boosted antiretroviral regimens Patients receive cabozantinib s-malate 60 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cabozantinib S-malate: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies	Stratum B - 60 mg/Day Patients taking either efavirenz or etravirine-based antiretroviral regimens Patients receive cabozantinib s-malate 60 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cabozantinib S-malate: Given PO	Stratum B - 100 mg/Day Patients taking either efavirenz or etravirine-based antiretroviral regimens Patients receive cabozantinib s-malate 100 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cabozantinib S-malate: Given PO	Stratum C - 60 mg/Day Patients who are on antiretroviral therapy that does not include agents in stratum A or B, or who were not on antiretroviral therapy Patients receive cabozantinib s-malate 60 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cabozantinib S-malate: Given PO
Overall Study STARTED	6	7	7	6	3	7
Overall Study COMPLETED	2	6	3	4	3	3
Overall Study NOT COMPLETED	4	1	4	2	0	4

Reasons for withdrawal

Measure	Stratum A - 20 mg/Day Patients taking either ritonavir-boosted or cobicistat-boosted antiretroviral regimens Patients receive cabozantinib s-malate 20 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cabozantinib S-malate: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies	Stratum A - 40 mg/Day Patients taking either ritonavir-boosted or cobicistat-boosted antiretroviral regimens Patients receive cabozantinib s-malate 40 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cabozantinib S-malate: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies	Stratum A - 60 mg/Day Patients taking either ritonavir-boosted or cobicistat-boosted antiretroviral regimens Patients receive cabozantinib s-malate 60 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cabozantinib S-malate: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies	Stratum B - 60 mg/Day Patients taking either efavirenz or etravirine-based antiretroviral regimens Patients receive cabozantinib s-malate 60 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cabozantinib S-malate: Given PO	Stratum B - 100 mg/Day Patients taking either efavirenz or etravirine-based antiretroviral regimens Patients receive cabozantinib s-malate 100 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cabozantinib S-malate: Given PO	Stratum C - 60 mg/Day Patients who are on antiretroviral therapy that does not include agents in stratum A or B, or who were not on antiretroviral therapy Patients receive cabozantinib s-malate 60 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cabozantinib S-malate: Given PO
Overall Study Adverse Event	1	1	1	0	0	1
Overall Study Death	3	0	2	0	0	0
Overall Study Lost to Follow-up	0	0	1	1	0	1
Overall Study Withdrawal by Subject	0	0	0	1	0	0
Overall Study Lack of Efficacy	0	0	0	0	0	2

Baseline Characteristics

Cabozantinib S-Malate in Treating Patients With Advanced Solid Tumors and Human Immunodeficiency Virus

Baseline characteristics by cohort

Measure	Stratum A - 20 mg/Day n=6 Participants Patients receive cabozantinib s-malate 20 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cabozantinib S-malate: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Patients in this stratum receive ritonavir-boosted or cobicistat-boosted antiretroviral therapy	Stratum A - 40 mg/Day n=7 Participants Patients receive cabozantinib s-malate 40 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cabozantinib S-malate: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Patients in this stratum receive ritonavir-boosted or cobicistat-boosted antiretroviral therapy	Stratum A - 60 mg/Day n=7 Participants Patients receive cabozantinib s-malate 60 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cabozantinib S-malate: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Patients in this stratum receive ritonavir-boosted or cobicistat-boosted antiretroviral therapy	Stratum B - 60 mg/Day n=6 Participants Patients receive cabozantinib s-malate 60 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cabozantinib S-malate: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Patients in this strata receive efavirenz or etravirine-based antiretroviral regimens	Stratum B - 100 mg/Day n=3 Participants Patients receive cabozantinib s-malate 100 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cabozantinib S-malate: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Patients in this strata receive efavirenz or etravirine-based antiretroviral regimens	Stratum C - 60 mg/Day n=7 Participants Patients receive cabozantinib s-malate 60 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cabozantinib S-malate: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Patients in this arm receive antiretroviral therapy that does not include the agents in stratum A or B, or are not on antiretroviral therapy	Total n=36 Participants Total of all reporting groups
Age, Continuous	50.8 years STANDARD_DEVIATION 14.9 • n=93 Participants	48.9 years STANDARD_DEVIATION 10.4 • n=4 Participants	45.9 years STANDARD_DEVIATION 13.0 • n=27 Participants	50.5 years STANDARD_DEVIATION 6.7 • n=483 Participants	48.0 years STANDARD_DEVIATION 7.8 • n=36 Participants	49.9 years STANDARD_DEVIATION 9.2 • n=10 Participants	49.0 years STANDARD_DEVIATION 10.3 • n=115 Participants
Sex: Female, Male Female	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants	1 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	3 Participants n=115 Participants
Sex: Female, Male Male	6 Participants n=93 Participants	6 Participants n=4 Participants	6 Participants n=27 Participants	5 Participants n=483 Participants	3 Participants n=36 Participants	7 Participants n=10 Participants	33 Participants n=115 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants	2 Participants n=483 Participants	1 Participants n=36 Participants	0 Participants n=10 Participants	7 Participants n=115 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=93 Participants	6 Participants n=4 Participants	6 Participants n=27 Participants	4 Participants n=483 Participants	2 Participants n=36 Participants	7 Participants n=10 Participants	29 Participants n=115 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Black or African American	1 Participants n=93 Participants	2 Participants n=4 Participants	4 Participants n=27 Participants	1 Participants n=483 Participants	1 Participants n=36 Participants	4 Participants n=10 Participants	13 Participants n=115 Participants
Race (NIH/OMB) White	4 Participants n=93 Participants	5 Participants n=4 Participants	2 Participants n=27 Participants	4 Participants n=483 Participants	2 Participants n=36 Participants	3 Participants n=10 Participants	20 Participants n=115 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants	1 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	2 Participants n=115 Participants
Region of Enrollment United States	6 participants n=93 Participants	7 participants n=4 Participants	7 participants n=27 Participants	6 participants n=483 Participants	3 participants n=36 Participants	7 participants n=10 Participants	36 participants n=115 Participants

PRIMARY outcome

Timeframe: Up to 30 days after completion of study treatment. Study treatment was between 1 and 82 weeks.

Will be reported using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The number of participant who experienced an adverse event

Outcome measures

Measure	Stratum A - 20 mg/Day n=6 Participants Patients who were on ritonavir-boosted or cobicistat-boosted antiretroviral regiments. Patients receive cabozantinib s-malate 20 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cabozantinib S-malate: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies	Stratum A - 40 mg/Day n=7 Participants Patients who were on ritonavir-boosted or cobicistat-boosted antiretroviral regiments. Patients receive cabozantinib s-malate 40 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cabozantinib S-malate: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies	Stratum A - 60 mg/Day n=7 Participants Patients who were on ritonavir-boosted or cobicistat-boosted antiretroviral regiments. Patients receive cabozantinib s-malate 60 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cabozantinib S-malate: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies	Stratum B - 60 mg/Day n=6 Participants Patients who are on efavirenz or etravirine-based antiretroviral regimens. Patients receive cabozantinib s-malate 60 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cabozantinib S-malate: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies	Stratum B - 100 mg/Day n=3 Participants Patients who are on efavirenz or etravirine-based antiretroviral regimens. Patients receive cabozantinib s-malate 100 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cabozantinib S-malate: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies	Stratum C n=7 Participants Patients who are not on the antiretroviral regimens specified in stratum A or B, or who were not on an antiretroviral regimen Patients receive cabozantinib s-malate PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cabozantinib S-malate: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies
Incidence of Adverse Events	6 Participants	7 Participants	7 Participants	6 Participants	3 Participants	7 Participants

PRIMARY outcome

Timeframe: Up to 28 days after treatment initiation

Will be graded according to the NCI CTCAE version 5.0. Dose-limiting toxicity (DLT) will be defined as any cabozantinib s-malate related grade 3 or 4 non-hematologic toxicity including grade 3 nausea and/or vomiting and grade 3 diarrhea despite prophylaxis and/or treatment or any of the following grade 4 hematologic toxicities: thrombocytopenia and neutropenia of any duration (with or without fever or documented infection); additionally, treatment delay of greater than 7 days due to unresolved toxicity or any dose reduction required due to a cabozantinib-related adverse event will be considered a DLT.

Outcome measures

Measure	Stratum A - 20 mg/Day n=20 Participants Patients who were on ritonavir-boosted or cobicistat-boosted antiretroviral regiments. Patients receive cabozantinib s-malate 20 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cabozantinib S-malate: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies	Stratum A - 40 mg/Day n=9 Participants Patients who were on ritonavir-boosted or cobicistat-boosted antiretroviral regiments. Patients receive cabozantinib s-malate 40 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cabozantinib S-malate: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies	Stratum A - 60 mg/Day n=7 Participants Patients who were on ritonavir-boosted or cobicistat-boosted antiretroviral regiments. Patients receive cabozantinib s-malate 60 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cabozantinib S-malate: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies	Stratum B - 60 mg/Day Patients who are on efavirenz or etravirine-based antiretroviral regimens. Patients receive cabozantinib s-malate 60 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cabozantinib S-malate: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies	Stratum B - 100 mg/Day Patients who are on efavirenz or etravirine-based antiretroviral regimens. Patients receive cabozantinib s-malate 100 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cabozantinib S-malate: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies	Stratum C Patients who are not on the antiretroviral regimens specified in stratum A or B, or who were not on an antiretroviral regimen Patients receive cabozantinib s-malate PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cabozantinib S-malate: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies
Maximal Tolerated Dose (MTD) of Cabozantinib-s-malate	20 mg/day	60 mg/day	60 mg/day	—	—	—

SECONDARY outcome

Timeframe: Up to 30 days after completion of study treatment. Study treatment was between 1 and 82 weeks. The median number 28-day cycles was 3.5.

Will be using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors guideline (version 1.1). Binomial proportions and their 95% confidence intervals will be used. Responses are categorized as complete or partial.

Outcome measures

Measure	Stratum A - 20 mg/Day n=6 Participants Patients who were on ritonavir-boosted or cobicistat-boosted antiretroviral regiments. Patients receive cabozantinib s-malate 20 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cabozantinib S-malate: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies	Stratum A - 40 mg/Day n=7 Participants Patients who were on ritonavir-boosted or cobicistat-boosted antiretroviral regiments. Patients receive cabozantinib s-malate 40 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cabozantinib S-malate: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies	Stratum A - 60 mg/Day n=7 Participants Patients who were on ritonavir-boosted or cobicistat-boosted antiretroviral regiments. Patients receive cabozantinib s-malate 60 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cabozantinib S-malate: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies	Stratum B - 60 mg/Day n=6 Participants Patients who are on efavirenz or etravirine-based antiretroviral regimens. Patients receive cabozantinib s-malate 60 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cabozantinib S-malate: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies	Stratum B - 100 mg/Day n=3 Participants Patients who are on efavirenz or etravirine-based antiretroviral regimens. Patients receive cabozantinib s-malate 100 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cabozantinib S-malate: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies	Stratum C n=7 Participants Patients who are not on the antiretroviral regimens specified in stratum A or B, or who were not on an antiretroviral regimen Patients receive cabozantinib s-malate PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cabozantinib S-malate: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies
Response Rates	0 Participants	0 Participants	1 Participants	2 Participants	0 Participants	2 Participants

SECONDARY outcome

Timeframe: Day 22 of treatment

Population: Participants who had HIV viral load measurements at visit 04

Detectable HIV viral load at visit 04 (day 22)

Outcome measures

Measure	Stratum A - 20 mg/Day n=6 Participants Patients who were on ritonavir-boosted or cobicistat-boosted antiretroviral regiments. Patients receive cabozantinib s-malate 20 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cabozantinib S-malate: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies	Stratum A - 40 mg/Day n=7 Participants Patients who were on ritonavir-boosted or cobicistat-boosted antiretroviral regiments. Patients receive cabozantinib s-malate 40 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cabozantinib S-malate: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies	Stratum A - 60 mg/Day n=7 Participants Patients who were on ritonavir-boosted or cobicistat-boosted antiretroviral regiments. Patients receive cabozantinib s-malate 60 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cabozantinib S-malate: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies	Stratum B - 60 mg/Day n=6 Participants Patients who are on efavirenz or etravirine-based antiretroviral regimens. Patients receive cabozantinib s-malate 60 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cabozantinib S-malate: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies	Stratum B - 100 mg/Day n=3 Participants Patients who are on efavirenz or etravirine-based antiretroviral regimens. Patients receive cabozantinib s-malate 100 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cabozantinib S-malate: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies	Stratum C n=7 Participants Patients who are not on the antiretroviral regimens specified in stratum A or B, or who were not on an antiretroviral regimen Patients receive cabozantinib s-malate PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cabozantinib S-malate: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies
Human Immunodeficiency Virus (HIV) Viral Load	3 Participants	4 Participants	2 Participants	3 Participants	1 Participants	4 Participants

SECONDARY outcome

Timeframe: Day 22 of treatment

Change in CD4 counts from baseline to visit 04

Outcome measures

Measure	Stratum A - 20 mg/Day n=3 Participants Patients who were on ritonavir-boosted or cobicistat-boosted antiretroviral regiments. Patients receive cabozantinib s-malate 20 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cabozantinib S-malate: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies	Stratum A - 40 mg/Day n=4 Participants Patients who were on ritonavir-boosted or cobicistat-boosted antiretroviral regiments. Patients receive cabozantinib s-malate 40 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cabozantinib S-malate: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies	Stratum A - 60 mg/Day n=2 Participants Patients who were on ritonavir-boosted or cobicistat-boosted antiretroviral regiments. Patients receive cabozantinib s-malate 60 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cabozantinib S-malate: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies	Stratum B - 60 mg/Day n=3 Participants Patients who are on efavirenz or etravirine-based antiretroviral regimens. Patients receive cabozantinib s-malate 60 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cabozantinib S-malate: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies	Stratum B - 100 mg/Day n=1 Participants Patients who are on efavirenz or etravirine-based antiretroviral regimens. Patients receive cabozantinib s-malate 100 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cabozantinib S-malate: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies	Stratum C n=4 Participants Patients who are not on the antiretroviral regimens specified in stratum A or B, or who were not on an antiretroviral regimen Patients receive cabozantinib s-malate PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cabozantinib S-malate: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies
CD4+ Cell Counts	41.0 cells/mm^3 Standard Deviation 31.2	30.0 cells/mm^3 Standard Deviation 45.2	64.5 cells/mm^3 Standard Deviation 92.6	23.0 cells/mm^3 Standard Deviation 127.6	33.0 cells/mm^3 Standard Deviation 0	-87.5 cells/mm^3 Standard Deviation 17.7

SECONDARY outcome

Timeframe: Day 22 of treatment

Population: Participants with baseline and visit 4 CD8 counts. Absolute CD8 counts were not collected on the study.

Change in CD8 cell counts from baseline to visit 04.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1

Population: Participants in stratum with Cmax levels at the maximum tolerated dose: 20 mg for stratum A, 60 mg for stratums B and C

Cmax at the maximum tolerated dose: 20 mg for stratum A, 60 mg for stratums B and C

Outcome measures

Measure	Stratum A - 20 mg/Day n=5 Participants Patients who were on ritonavir-boosted or cobicistat-boosted antiretroviral regiments. Patients receive cabozantinib s-malate 20 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cabozantinib S-malate: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies	Stratum A - 40 mg/Day n=6 Participants Patients who were on ritonavir-boosted or cobicistat-boosted antiretroviral regiments. Patients receive cabozantinib s-malate 40 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cabozantinib S-malate: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies	Stratum A - 60 mg/Day n=6 Participants Patients who were on ritonavir-boosted or cobicistat-boosted antiretroviral regiments. Patients receive cabozantinib s-malate 60 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cabozantinib S-malate: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies	Stratum B - 60 mg/Day Patients who are on efavirenz or etravirine-based antiretroviral regimens. Patients receive cabozantinib s-malate 60 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cabozantinib S-malate: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies	Stratum B - 100 mg/Day Patients who are on efavirenz or etravirine-based antiretroviral regimens. Patients receive cabozantinib s-malate 100 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cabozantinib S-malate: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies	Stratum C Patients who are not on the antiretroviral regimens specified in stratum A or B, or who were not on an antiretroviral regimen Patients receive cabozantinib s-malate PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cabozantinib S-malate: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies
Pharmacokinetic Parameters	683 ng/ml Standard Deviation 147	521 ng/ml Standard Deviation 293	1239 ng/ml Standard Deviation 422	—	—	—

Adverse Events

Stratum A - 20 mg/Day

Serious events: 3 serious events

Other events: 6 other events

Deaths: 3 deaths

Stratum A - 40 mg/Day

Serious events: 1 serious events

Other events: 7 other events

Deaths: 3 deaths

Stratum A - 60 mg/Day

Serious events: 5 serious events

Other events: 7 other events

Deaths: 0 deaths

Stratum B - 60 mg/Day

Serious events: 3 serious events

Other events: 6 other events

Deaths: 0 deaths

Stratum B - 100 mg/Day

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Stratum C - 60 mg/Day

Serious events: 2 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Measure	Stratum A - 20 mg/Day n=6 participants at risk Patients on ritonavir-boosted or cobicistat-boosted antiretroviral therapy Patients receive cabozantinib s-malate 20 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cabozantinib S-malate: Given PO	Stratum A - 40 mg/Day n=7 participants at risk Patients on ritonavir-boosted or cobicistat-boosted antiretroviral therapy Patients receive cabozantinib s-malate 40 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cabozantinib S-malate: Given PO	Stratum A - 60 mg/Day n=7 participants at risk Patients on ritonavir-boosted or cobicistat-boosted antiretroviral therapy Patients receive cabozantinib s-malate 60 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cabozantinib S-malate: Given PO	Stratum B - 60 mg/Day n=6 participants at risk Patients on efavirenz or etravirine-boosted antiretroviral therapy Patients receive cabozantinib s-malate 60 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cabozantinib S-malate: Given PO	Stratum B - 100 mg/Day n=3 participants at risk Patients on efavirenz or etravirine-boosted antiretroviral therapy Patients receive cabozantinib s-malate 100 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cabozantinib S-malate: Given PO	Stratum C - 60 mg/Day n=7 participants at risk Patients who were on antiretroviral therapy that did not include the agents in stratums A or B, or were not on antiretroviral therapy. Patients receive cabozantinib s-malate 60 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cabozantinib S-malate: Given PO
Cardiac disorders atrioventricular block	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Cardiac disorders cardiac arrest	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Cardiac disorders chest pain	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Cardiac disorders pericardial effusion	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Cardiac disorders pericardial tamonade	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Gastrointestinal disorders abdominal pain	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
General disorders disease progression	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
General disorders fever	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Infections and infestations bronchial infection	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Infections and infestations Necrotizing fasciitis	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Infections and infestations skin infection	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	33.3% 1/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Infections and infestations small intestine infection	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Musculoskeletal and connective tissue disorders back pain	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Musculoskeletal and connective tissue disorders pain in extremity	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Progressive disease	33.3% 2/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	28.6% 2/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) tumor pain	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Nervous system disorders seizure	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Nervous system disorders stroke	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Renal and urinary disorders hematuria	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Renal and urinary disorders urinary retention	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Vascular disorders arterial thromboembolism	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Infections and infestations MRSA	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.

Other adverse events

Measure	Stratum A - 20 mg/Day n=6 participants at risk Patients on ritonavir-boosted or cobicistat-boosted antiretroviral therapy Patients receive cabozantinib s-malate 20 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cabozantinib S-malate: Given PO	Stratum A - 40 mg/Day n=7 participants at risk Patients on ritonavir-boosted or cobicistat-boosted antiretroviral therapy Patients receive cabozantinib s-malate 40 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cabozantinib S-malate: Given PO	Stratum A - 60 mg/Day n=7 participants at risk Patients on ritonavir-boosted or cobicistat-boosted antiretroviral therapy Patients receive cabozantinib s-malate 60 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cabozantinib S-malate: Given PO	Stratum B - 60 mg/Day n=6 participants at risk Patients on efavirenz or etravirine-boosted antiretroviral therapy Patients receive cabozantinib s-malate 60 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cabozantinib S-malate: Given PO	Stratum B - 100 mg/Day n=3 participants at risk Patients on efavirenz or etravirine-boosted antiretroviral therapy Patients receive cabozantinib s-malate 100 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cabozantinib S-malate: Given PO	Stratum C - 60 mg/Day n=7 participants at risk Patients who were on antiretroviral therapy that did not include the agents in stratums A or B, or were not on antiretroviral therapy. Patients receive cabozantinib s-malate 60 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cabozantinib S-malate: Given PO
Eye disorders Eye discharge	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Blood and lymphatic system disorders anemia	50.0% 3/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	28.6% 2/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	33.3% 1/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Endocrine disorders TSH increased	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Endocrine disorders hypothyroidism	33.3% 2/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	28.6% 2/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	42.9% 3/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	28.6% 2/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Eye disorders blurred vision	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	28.6% 2/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Gastrointestinal disorders abdominal pain	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	28.6% 2/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Gastrointestinal disorders constipation	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	28.6% 2/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	50.0% 3/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Gastrointestinal disorders diarrhea	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	57.1% 4/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	71.4% 5/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	50.0% 3/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	66.7% 2/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	85.7% 6/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Ear and labyrinth disorders Hearing impaired	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Gastrointestinal disorders dry mouth	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Gastrointestinal disorders dyspepsia	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	28.6% 2/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Ear and labyrinth disorders Vertigo	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Gastrointestinal disorders dysphagia	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Gastrointestinal disorders gastroesophageal reflux	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	57.1% 4/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	33.3% 2/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Gastrointestinal disorders Gums bleeding	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Gastrointestinal disorders oral mucositis	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	28.6% 2/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	28.6% 2/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	33.3% 1/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Gastrointestinal disorders nausea	33.3% 2/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	57.1% 4/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	71.4% 5/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	66.7% 4/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	71.4% 5/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Gastrointestinal disorders oral pain	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Gastrointestinal disorders proctitis	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Gastrointestinal disorders rectal hemorrhage	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Gastrointestinal disorders rectal pain	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	28.6% 2/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Gastrointestinal disorders vomiting	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	57.1% 4/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	33.3% 2/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	42.9% 3/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
General disorders chills	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	33.3% 1/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
General disorders limb edema	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
General disorders fatigue	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	57.1% 4/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	28.6% 2/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	83.3% 5/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	57.1% 4/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
General disorders fever	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	33.3% 1/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
General disorders flu like symptoms	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
General disorders night sweats	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
General disorders non cardiac chest pain	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	28.6% 2/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
General disorders pain	33.3% 2/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Infections and infestations gum infection	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	28.6% 2/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Infections and infestations Increased RPR titer	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Infections and infestations skin infection	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	28.6% 2/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	33.3% 2/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Infections and infestations upper respiratory infection	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Infections and infestations urinary tract infection	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Injury, poisoning and procedural complications bruising	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Injury, poisoning and procedural complications fall	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Investigations activated partial thromboplastin time prolonged	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Investigations alanine aminotransferase increased	50.0% 3/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	42.9% 3/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	42.9% 3/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	33.3% 2/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	33.3% 1/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	42.9% 3/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Endocrine disorders Hyperthyroidism	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Investigations increased alkaline phosphatase	50.0% 3/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	33.3% 1/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Investigations blood bilirubin increased	33.3% 2/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	28.6% 2/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Investigations LDH elevated	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	28.6% 2/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	33.3% 1/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Investigations increased creatinine	33.3% 2/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Investigations INR increased	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Investigations lipase increased	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	33.3% 1/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Investigations lymphocyte count increased	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	28.6% 2/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	33.3% 1/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Investigations neutrophil count decreased	50.0% 3/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	28.6% 2/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	28.6% 2/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	66.7% 2/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	57.1% 4/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Investigations lymphocyte count decreased	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	33.3% 1/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Investigations platelet count decreased	33.3% 2/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	66.7% 2/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	42.9% 3/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Investigations weight loss	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Investigations white blood cell decreased	33.3% 2/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	42.9% 3/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	28.6% 2/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	66.7% 2/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	28.6% 2/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Metabolism and nutrition disorders anorexia	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	33.3% 2/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	33.3% 1/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	28.6% 2/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Metabolism and nutrition disorders hypercalcemia	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Metabolism and nutrition disorders hyperglycemia	33.3% 2/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	28.6% 2/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	33.3% 1/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Metabolism and nutrition disorders hyperkalemia	33.3% 2/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	33.3% 2/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Metabolism and nutrition disorders hypermagnesemia	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	28.6% 2/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	33.3% 1/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Metabolism and nutrition disorders hypoalbuminemia	33.3% 2/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	28.6% 2/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	66.7% 2/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Metabolism and nutrition disorders hypocalcemia	50.0% 3/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	28.6% 2/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	66.7% 2/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Metabolism and nutrition disorders hypokalemia	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	28.6% 2/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	33.3% 1/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Metabolism and nutrition disorders hypomagnesemia	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	33.3% 2/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	33.3% 1/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Metabolism and nutrition disorders hyponatremia	50.0% 3/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	28.6% 2/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	66.7% 4/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Metabolism and nutrition disorders hypophosphatemia	50.0% 3/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	28.6% 2/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	66.7% 2/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	28.6% 2/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Metabolism and nutrition disorders Elevated serum protein	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	28.6% 2/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	28.6% 2/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Musculoskeletal and connective tissue disorders arthralgia	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	28.6% 2/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Musculoskeletal and connective tissue disorders back pain	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	28.6% 2/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Musculoskeletal and connective tissue disorders bone pain	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	28.6% 2/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Musculoskeletal and connective tissue disorders muscle weakness lower limb	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Musculoskeletal and connective tissue disorders right knee strain	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Musculoskeletal and connective tissue disorders myalgia	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Musculoskeletal and connective tissue disorders myositis	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Musculoskeletal and connective tissue disorders pain in extremity	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Nervous system disorders dizziness	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	28.6% 2/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	33.3% 2/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Nervous system disorders dysgeusia	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	33.3% 2/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	28.6% 2/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Nervous system disorders headache	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	28.6% 2/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Nervous system disorders paresthesia	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	28.6% 2/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Nervous system disorders peripheral sensory neuropathy	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	42.9% 3/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Psychiatric disorders insomnia	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Renal and urinary disorders hematuria	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	28.6% 2/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	33.3% 2/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Renal and urinary disorders proteinuria	33.3% 2/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	28.6% 2/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	28.6% 2/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	83.3% 5/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	100.0% 3/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Renal and urinary disorders Ketones in urine	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Renal and urinary disorders renal calculi	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Renal and urinary disorders urinary retention	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Respiratory, thoracic and mediastinal disorders cough	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Respiratory, thoracic and mediastinal disorders dyspnea	33.3% 2/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	33.3% 2/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Respiratory, thoracic and mediastinal disorders hypoxia	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Respiratory, thoracic and mediastinal disorders nasal congestion	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Respiratory, thoracic and mediastinal disorders post nasal drip	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Respiratory, thoracic and mediastinal disorders Elevated carbon dioxide	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Respiratory, thoracic and mediastinal disorders sore throat	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Skin and subcutaneous tissue disorders alopecia	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Skin and subcutaneous tissue disorders dry skin	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	42.9% 3/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	42.9% 3/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Skin and subcutaneous tissue disorders palmar-plantar erythrodysesthesia syndrome	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	57.1% 4/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	71.4% 5/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	33.3% 1/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	28.6% 2/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Skin and subcutaneous tissue disorders pruritus	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Skin and subcutaneous tissue disorders maculo-papular rash	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	28.6% 2/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	28.6% 2/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Skin and subcutaneous tissue disorders Hair graying	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	28.6% 2/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	28.6% 2/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Skin and subcutaneous tissue disorders skin hypopigmentation	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	28.6% 2/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Vascular disorders hot flashes	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	28.6% 2/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	28.6% 2/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Vascular disorders hypertension	50.0% 3/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	57.1% 4/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	57.1% 4/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	100.0% 3/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	28.6% 2/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Blood and lymphatic system disorders decreased eosinophils	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	28.6% 2/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	33.3% 1/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Blood and lymphatic system disorders Increased monocytes	33.3% 2/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Blood and lymphatic system disorders Decrease Monocytes	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	42.9% 3/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	28.6% 2/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	33.3% 1/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Blood and lymphatic system disorders Decreased RBC	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	33.3% 1/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Cardiac disorders Splenic and Kidney infarcts	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Cardiac disorders Sinus bradycardia	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Cardiac disorders Sinus tachycardia	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Gastrointestinal disorders Anal fistula	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Gastrointestinal disorders Anal hemorrhage	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Gastrointestinal disorders Colonic fistula	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Gastrointestinal disorders Flatulence	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Gastrointestinal disorders Stomach tenderness	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Gastrointestinal disorders Altered bowel movement pattern	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Gastrointestinal disorders Canker sores	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Gastrointestinal disorders Oral dysesthesia	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Gastrointestinal disorders Toothache	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
General disorders Loss of balance	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
General disorders Localized edema	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Hepatobiliary disorders Cholecystitis	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Hepatobiliary disorders Elevated Urogilinogen	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Infections and infestations Anorectal infection	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Infections and infestations Bladder infection	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Infections and infestations Shingles	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Infections and infestations Periodontal disease	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Infections and infestations Laryngitis	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Infections and infestations Lip infection	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Infections and infestations Nail infection	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Infections and infestations Papulopustular Rash	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Infections and infestations Sinusitis	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Infections and infestations Soft tissue infection	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Injury, poisoning and procedural complications Food poisoning	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Injury, poisoning and procedural complications Spinal fracture	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Investigations aspartate aminotransferase increased	50.0% 3/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	57.1% 4/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	42.9% 3/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	50.0% 3/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	33.3% 1/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	28.6% 2/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Investigations Blood lactate dehydrogenase increased	33.3% 2/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Investigations CD4 lymphocytes decreased	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Investigations Hemoglobin increased	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Investigations MCV elevated	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	28.6% 2/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	33.3% 1/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Investigations Elevated urea nitrogen	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Investigations Abnormal EKG	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Investigations Elevated PSA	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Investigations Elevated Neutrophils	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	33.3% 1/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Investigations Elevated basophils	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Metabolism and nutrition disorders Elevated chloride	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	33.3% 2/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	66.7% 2/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Metabolism and nutrition disorders Decreased chloride	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	28.6% 2/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Metabolism and nutrition disorders Leukocyturia	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	28.6% 2/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Investigations Serum amylase increased	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	33.3% 2/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	33.3% 1/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Investigations Thyroid stimulating hormone increased	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Investigations Weight gain	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Metabolism and nutrition disorders Acidosis	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Metabolism and nutrition disorders Dehydration	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Musculoskeletal and connective tissue disorders Left hip pain	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Musculoskeletal and connective tissue disorders Muscle cramp in legs	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Nervous system disorders Lethargy	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Nervous system disorders Right peripheral vision loss	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Nervous system disorders Peripheral motor neuropathy	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Nervous system disorders Presyncope	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	33.3% 1/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Nervous system disorders Somnolence	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Psychiatric disorders Agitation	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Psychiatric disorders Anxiety	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Psychiatric disorders Delirium	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Psychiatric disorders Depression	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Renal and urinary disorders Hemoglobinuria	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	33.3% 1/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Renal and urinary disorders Leucocyte in urine	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Renal and urinary disorders Bacteria in urine	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	33.3% 1/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Psychiatric disorders Irritability	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Renal and urinary disorders Urinary frequency	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Renal and urinary disorders Urinary tract obstruction	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Reproductive system and breast disorders Breast pain	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Reproductive system and breast disorders Erectile dysfunction	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	33.3% 1/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Reproductive system and breast disorders Gynecological pain	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Reproductive system and breast disorders Pelvic pain	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Respiratory, thoracic and mediastinal disorders Bronchial stricture	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Respiratory, thoracic and mediastinal disorders Bronchial obstruction	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Respiratory, thoracic and mediastinal disorders Bronchopulmonary hemorrhage	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Respiratory, thoracic and mediastinal disorders Hoarseness	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Respiratory, thoracic and mediastinal disorders Pulmonary edema	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Respiratory, thoracic and mediastinal disorders Increased urea nitrogen	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Respiratory, thoracic and mediastinal disorders Decreased carbon dioxide	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Respiratory, thoracic and mediastinal disorders Sinus pain	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Respiratory, thoracic and mediastinal disorders Sleep apnea	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Skin and subcutaneous tissue disorders Bullous dermatitis	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Skin and subcutaneous tissue disorders Nail coloration	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Skin and subcutaneous tissue disorders Increased sensitivity to heat and cold	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Skin and subcutaneous tissue disorders Poison ivy	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Skin and subcutaneous tissue disorders Porokeratosis	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Skin and subcutaneous tissue disorders Hair color lightening	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	33.3% 1/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Skin and subcutaneous tissue disorders Exfoliative rash	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Skin and subcutaneous tissue disorders Skin induration	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	33.3% 1/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Skin and subcutaneous tissue disorders Skin ulceration	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Vascular disorders Hypotension	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Skin and subcutaneous tissue disorders Thromboemolic event	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	16.7% 1/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.
Vascular disorders Feels hot and cold (alternating)	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	14.3% 1/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/6 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/3 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.	0.00% 0/7 • 30 days after end of treatment. Treatment ranged from 1 to 81 28-day cycles. The median number of cycles was 3.5 cycles.

Additional Information

Kim Mosby-Griffin

AMC Operations and Data Management Cener

Phone: 301-251-1161

Email: kmosby@emmes.com

Results disclosure agreements

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

Restriction type: LTE60