Trial Outcomes & Findings for A Study to Evaluate TAK-931 in Participants With Advanced Nonhematologic Tumors (NCT NCT02699749)

Last Updated: 2021-02-21

Results Overview

Toxicity was evaluated by NCI CTCAE v4.03. DLT:any of following occurred events during Cycle 1 considered by investigator to be possibly related to therapy:1)Grade4 neutropenia,2)Febrile neutropenia lasting greater(\>)1 hour,3)Grade greater than or equal to (\>=)3 neutropenia with infection,4)Grade \>=3 thrombocytopenia with bleeding,4)Grade 4 thrombocytopenia,5)delay in initiation of Cycle 2 by \>14 days,6)Grade 2:\<Grade 2 ejection fraction,7)other Grade 2 nonhematologic toxicities considered by investigator related to study drug and DLTs,8)who received \<50 percent of doses of planned TAK-931 dosing in Cycle 1 for related AEs:\<7 QD/\<14 BID doses (Schedules A,B);\<11 QD/\<21 BID doses(Schedule D),\<3 QD/\<6 BID doses for(Schedule E),9)Grade \>=3 nonhematologic toxicity except arthralgia/myalgia and fatigue, isolated \>=Grade 3 laboratory abnormalities if it is asymptomatic and resolves to \<=Grade 1 or baseline levels in \<=7 days;inadequately treated Grade 3 nausea and/or vomiting and diarrhea.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

80 participants

Primary outcome timeframe

Baseline up to Cycle 1 (Cycle length= 21 days [Schedules A, D and E] and 28 days [Schedule B])

Results posted on

2021-02-21

Participant Flow

Participants took part in the study at 2 investigative sites in Japan from 24 March 2016 to 21 December 2019.

Participants with advanced nonhematological solid tumors were enrolled to receive TAK-931 in 1 of the 4 treatment schedules: Schedule A, Schedule B, Schedule D and Schedule E. Schedules C and F were not conducted due to business reasons.

Participant milestones

Participant milestones
Measure	Schedule A: TAK-931 30 mg TAK-931 30 milligram (mg), capsule, orally, once daily (QD) for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule A: TAK-931 40 mg TAK-931 40 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule A: TAK-931 50 mg TAK-931 50 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule A: TAK-931 60 mg TAK-931 60 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule B: TAK-931 60 mg TAK-931 60 mg, capsule, orally, once daily or twice daily (BID) for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule B: TAK-931 80 mg TAK-931 80 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule B: TAK-931 100 mg TAK-931 100 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule B: TAK-931 120 mg TAK-931 120 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule D: TAK-931 20 mg TAK-931 20 mg, capsule, orally, once daily in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule D: TAK-931 30 mg TAK-931 30 mg, capsule, orally, once daily in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule D: TAK-931 40 mg TAK-931 40 mg, capsule, orally, once daily in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule E: TAK-931 100 mg TAK-931 100 mg, capsule, orally, once daily on Days 1 and 2 followed by 5 days of rest and repeated weekly (2 days on and 5 days off treatment) in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule E: TAK-931 120 mg TAK-931 120 mg, capsule, orally, once daily on Days 1 and 2 followed by 5 days of rest and repeated weekly (2 days on and 5 days off treatment) in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule E: TAK-931 150 mg TAK-931 150 mg, capsule, orally, once daily on Days 1 and 2 followed by 5 days of rest and repeated weekly (2 days on and 5 days off treatment) in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.
Overall Study STARTED	3	3	16	3	3	9	6	6	6	6	6	4	3	6
Overall Study COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Overall Study NOT COMPLETED	3	3	16	3	3	9	6	6	6	6	6	4	3	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Schedule A: TAK-931 30 mg TAK-931 30 milligram (mg), capsule, orally, once daily (QD) for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule A: TAK-931 40 mg TAK-931 40 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule A: TAK-931 50 mg TAK-931 50 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule A: TAK-931 60 mg TAK-931 60 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule B: TAK-931 60 mg TAK-931 60 mg, capsule, orally, once daily or twice daily (BID) for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule B: TAK-931 80 mg TAK-931 80 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule B: TAK-931 100 mg TAK-931 100 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule B: TAK-931 120 mg TAK-931 120 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule D: TAK-931 20 mg TAK-931 20 mg, capsule, orally, once daily in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule D: TAK-931 30 mg TAK-931 30 mg, capsule, orally, once daily in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule D: TAK-931 40 mg TAK-931 40 mg, capsule, orally, once daily in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule E: TAK-931 100 mg TAK-931 100 mg, capsule, orally, once daily on Days 1 and 2 followed by 5 days of rest and repeated weekly (2 days on and 5 days off treatment) in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule E: TAK-931 120 mg TAK-931 120 mg, capsule, orally, once daily on Days 1 and 2 followed by 5 days of rest and repeated weekly (2 days on and 5 days off treatment) in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule E: TAK-931 150 mg TAK-931 150 mg, capsule, orally, once daily on Days 1 and 2 followed by 5 days of rest and repeated weekly (2 days on and 5 days off treatment) in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.
Overall Study Other	0	0	2	0	0	1	1	0	0	0	1	0	0	0
Overall Study Progressive Disease	3	3	14	3	3	7	5	5	6	6	5	4	3	5
Overall Study Death	0	0	0	0	0	0	0	0	0	0	0	0	0	1
Overall Study Lost to Follow-up	0	0	0	0	0	1	0	1	0	0	0	0	0	0

Baseline Characteristics

A Study to Evaluate TAK-931 in Participants With Advanced Nonhematologic Tumors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Schedule A: TAK-931 30 mg n=3 Participants TAK-931 30 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule A: TAK-931 40 mg n=3 Participants TAK-931 40 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule A: TAK-931 50 mg n=16 Participants TAK-931 50 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule A: TAK-931 60 mg n=3 Participants TAK-931 60 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule B: TAK-931 60 mg n=3 Participants TAK-931 60 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule B: TAK-931 80 mg n=9 Participants TAK-931 80 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule B: TAK-931 100 mg n=6 Participants TAK-931 100 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule B: TAK-931 120 mg n=6 Participants TAK-931 120 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule D: TAK-931 20 mg n=6 Participants TAK-931 20 mg, capsule, orally, once daily in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule D: TAK-931 30 mg n=6 Participants TAK-931 30 mg, capsule, orally, once daily in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule D: TAK-931 40 mg n=6 Participants TAK-931 40 mg, capsule, orally, once daily in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule E: TAK-931 100 mg n=4 Participants TAK-931 100 mg, capsule, orally, once daily on Days 1 and 2 followed by 5 days of rest and repeated weekly (2 days on and 5 days off treatment) in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule E: TAK-931 120 mg n=3 Participants TAK-931 120 mg, capsule, orally, once daily on Days 1 and 2 followed by 5 days of rest and repeated weekly (2 days on and 5 days off treatment) in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule E: TAK-931 150 mg n=6 Participants TAK-931 150 mg, capsule, orally, once daily on Days 1 and 2 followed by 5 days of rest and repeated weekly (2 days on and 5 days off treatment) in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Total n=80 Participants Total of all reporting groups
Sex: Female, Male Female	0 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants	3 Participants n=4 Participants	1 Participants n=21 Participants	5 Participants n=8 Participants	1 Participants n=8 Participants	2 Participants n=24 Participants	3 Participants n=42 Participants	3 Participants n=42 Participants	2 Participants n=42 Participants	2 Participants n=42 Participants	2 Participants n=36 Participants	1 Participants n=36 Participants	32 Participants n=24 Participants
Age, Continuous	62.7 years STANDARD_DEVIATION 6.81 • n=5 Participants	56.7 years STANDARD_DEVIATION 2.52 • n=7 Participants	57.4 years STANDARD_DEVIATION 11.99 • n=5 Participants	59.3 years STANDARD_DEVIATION 1.53 • n=4 Participants	61.7 years STANDARD_DEVIATION 3.21 • n=21 Participants	52.4 years STANDARD_DEVIATION 13.45 • n=8 Participants	50.0 years STANDARD_DEVIATION 8.15 • n=8 Participants	59.8 years STANDARD_DEVIATION 12.01 • n=24 Participants	59.3 years STANDARD_DEVIATION 6.56 • n=42 Participants	62.7 years STANDARD_DEVIATION 8.09 • n=42 Participants	58.3 years STANDARD_DEVIATION 17.41 • n=42 Participants	59.5 years STANDARD_DEVIATION 2.38 • n=42 Participants	60.7 years STANDARD_DEVIATION 13.58 • n=36 Participants	62.8 years STANDARD_DEVIATION 12.40 • n=36 Participants	58.1 years STANDARD_DEVIATION 10.74 • n=24 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	1 Participants n=7 Participants	11 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants	4 Participants n=8 Participants	5 Participants n=8 Participants	4 Participants n=24 Participants	3 Participants n=42 Participants	3 Participants n=42 Participants	4 Participants n=42 Participants	2 Participants n=42 Participants	1 Participants n=36 Participants	5 Participants n=36 Participants	48 Participants n=24 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	3 Participants n=7 Participants	16 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	9 Participants n=8 Participants	6 Participants n=8 Participants	6 Participants n=24 Participants	6 Participants n=42 Participants	6 Participants n=42 Participants	6 Participants n=42 Participants	4 Participants n=42 Participants	3 Participants n=36 Participants	6 Participants n=36 Participants	80 Participants n=24 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants
Region of Enrollment Japan	3 Participants n=5 Participants	3 Participants n=7 Participants	16 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	9 Participants n=8 Participants	6 Participants n=8 Participants	6 Participants n=24 Participants	6 Participants n=42 Participants	6 Participants n=42 Participants	6 Participants n=42 Participants	4 Participants n=42 Participants	3 Participants n=36 Participants	6 Participants n=36 Participants	80 Participants n=24 Participants
Height	169.67 centimeter (cm) STANDARD_DEVIATION 8.663 • n=5 Participants	159.70 centimeter (cm) STANDARD_DEVIATION 7.076 • n=7 Participants	165.39 centimeter (cm) STANDARD_DEVIATION 6.727 • n=5 Participants	155.03 centimeter (cm) STANDARD_DEVIATION 4.306 • n=4 Participants	162.80 centimeter (cm) STANDARD_DEVIATION 11.012 • n=21 Participants	163.64 centimeter (cm) STANDARD_DEVIATION 9.107 • n=8 Participants	168.73 centimeter (cm) STANDARD_DEVIATION 7.387 • n=8 Participants	167.40 centimeter (cm) STANDARD_DEVIATION 9.586 • n=24 Participants	160.08 centimeter (cm) STANDARD_DEVIATION 12.071 • n=42 Participants	156.43 centimeter (cm) STANDARD_DEVIATION 8.913 • n=42 Participants	163.87 centimeter (cm) STANDARD_DEVIATION 7.469 • n=42 Participants	162.43 centimeter (cm) STANDARD_DEVIATION 9.280 • n=42 Participants	155.90 centimeter (cm) STANDARD_DEVIATION 12.612 • n=36 Participants	165.92 centimeter (cm) STANDARD_DEVIATION 8.817 • n=36 Participants	163.41 centimeter (cm) STANDARD_DEVIATION 8.890 • n=24 Participants
Weight	70.07 kilogram (kg) STANDARD_DEVIATION 18.269 • n=5 Participants	55.33 kilogram (kg) STANDARD_DEVIATION 3.099 • n=7 Participants	62.06 kilogram (kg) STANDARD_DEVIATION 10.535 • n=5 Participants	50.53 kilogram (kg) STANDARD_DEVIATION 3.707 • n=4 Participants	58.03 kilogram (kg) STANDARD_DEVIATION 8.686 • n=21 Participants	66.51 kilogram (kg) STANDARD_DEVIATION 16.750 • n=8 Participants	71.00 kilogram (kg) STANDARD_DEVIATION 10.769 • n=8 Participants	65.85 kilogram (kg) STANDARD_DEVIATION 10.783 • n=24 Participants	59.63 kilogram (kg) STANDARD_DEVIATION 16.675 • n=42 Participants	51.08 kilogram (kg) STANDARD_DEVIATION 10.167 • n=42 Participants	56.25 kilogram (kg) STANDARD_DEVIATION 13.248 • n=42 Participants	61.30 kilogram (kg) STANDARD_DEVIATION 13.851 • n=42 Participants	53.27 kilogram (kg) STANDARD_DEVIATION 13.250 • n=36 Participants	58.55 kilogram (kg) STANDARD_DEVIATION 13.772 • n=36 Participants	60.91 kilogram (kg) STANDARD_DEVIATION 12.964 • n=24 Participants
Body Surface Area (BSA)	1.810 square meter (m˄2) STANDARD_DEVIATION 0.2805 • n=5 Participants	1.563 square meter (m˄2) STANDARD_DEVIATION 0.0757 • n=7 Participants	1.684 square meter (m˄2) STANDARD_DEVIATION 0.1513 • n=5 Participants	1.473 square meter (m˄2) STANDARD_DEVIATION 0.0569 • n=4 Participants	1.617 square meter (m˄2) STANDARD_DEVIATION 0.1620 • n=21 Participants	1.732 square meter (m˄2) STANDARD_DEVIATION 0.2538 • n=8 Participants	1.820 square meter (m˄2) STANDARD_DEVIATION 0.1510 • n=8 Participants	1.747 square meter (m˄2) STANDARD_DEVIATION 0.1904 • n=24 Participants	1.620 square meter (m˄2) STANDARD_DEVIATION 0.2922 • n=42 Participants	1.485 square meter (m˄2) STANDARD_DEVIATION 0.1660 • n=42 Participants	1.595 square meter (m˄2) STANDARD_DEVIATION 0.2134 • n=42 Participants	1.658 square meter (m˄2) STANDARD_DEVIATION 0.2323 • n=42 Participants	1.513 square meter (m˄2) STANDARD_DEVIATION 0.2501 • n=36 Participants	1.637 square meter (m˄2) STANDARD_DEVIATION 0.2284 • n=36 Participants	1.656 square meter (m˄2) STANDARD_DEVIATION 0.2095 • n=24 Participants

PRIMARY outcome

Timeframe: Baseline up to Cycle 1 (Cycle length= 21 days [Schedules A, D and E] and 28 days [Schedule B])

Population: The DLT-evaluable population was defined as all participants who received at least 75% of their planned TAK-931 doses for their first cycle of treatment (unless interrupted by study drug-related AEs) and who had sufficient follow-up data to allow the investigators and sponsor to determine whether DLT occurred.

Outcome measures

Outcome measures
Measure	Schedule E: TAK-931 120 mg n=3 Participants TAK-931 120 mg, capsule, orally, once daily on Days 1 and 2 followed by 5 days of rest and repeated weekly (2 days on and 5 days off treatment) in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule E: TAK-931 150 mg n=6 Participants TAK-931 150 mg, capsule, orally, once daily on Days 1 and 2 followed by 5 days of rest and repeated weekly (2 days on and 5 days off treatment) in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule A: TAK-931 30 mg n=3 Participants TAK-931 30 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule A: TAK-931 40 mg n=3 Participants TAK-931 40 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule A: TAK-931 50 mg n=16 Participants TAK-931 50 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule A: TAK-931 60 mg n=3 Participants TAK-931 60 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule B: TAK-931 60 mg n=3 Participants TAK-931 60 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule B: TAK-931 80 mg n=9 Participants TAK-931 80 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule B: TAK-931 100 mg n=6 Participants TAK-931 100 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule B: TAK-931 120 mg n=6 Participants TAK-931 120 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule D: TAK-931 20 mg n=6 Participants TAK-931 20 mg, capsule, orally, once daily in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule D: TAK-931 30 mg n=6 Participants TAK-931 30 mg, capsule, orally, once daily in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule D: TAK-931 40 mg n=6 Participants TAK-931 40 mg, capsule, orally, once daily in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule E: TAK-931 100 mg n=4 Participants TAK-931 100 mg, capsule, orally, once daily on Days 1 and 2 followed by 5 days of rest and repeated weekly (2 days on and 5 days off treatment) in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.
Number of Participants With Dose Limiting Toxicities (DLTs) Assessed by National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Version 4.03	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	2 Participants	1 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants

PRIMARY outcome

Timeframe: Baseline up to 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (up to Day 499)

Population: The safety population was defined as all participants who received any amount of study drug.

Outcome measures

Outcome measures
Measure	Schedule E: TAK-931 120 mg n=3 Participants TAK-931 120 mg, capsule, orally, once daily on Days 1 and 2 followed by 5 days of rest and repeated weekly (2 days on and 5 days off treatment) in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule E: TAK-931 150 mg n=6 Participants TAK-931 150 mg, capsule, orally, once daily on Days 1 and 2 followed by 5 days of rest and repeated weekly (2 days on and 5 days off treatment) in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule A: TAK-931 30 mg n=3 Participants TAK-931 30 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule A: TAK-931 40 mg n=3 Participants TAK-931 40 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule A: TAK-931 50 mg n=16 Participants TAK-931 50 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule A: TAK-931 60 mg n=3 Participants TAK-931 60 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule B: TAK-931 60 mg n=3 Participants TAK-931 60 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule B: TAK-931 80 mg n=9 Participants TAK-931 80 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule B: TAK-931 100 mg n=6 Participants TAK-931 100 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule B: TAK-931 120 mg n=6 Participants TAK-931 120 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule D: TAK-931 20 mg n=6 Participants TAK-931 20 mg, capsule, orally, once daily in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule D: TAK-931 30 mg n=6 Participants TAK-931 30 mg, capsule, orally, once daily in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule D: TAK-931 40 mg n=6 Participants TAK-931 40 mg, capsule, orally, once daily in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule E: TAK-931 100 mg n=4 Participants TAK-931 100 mg, capsule, orally, once daily on Days 1 and 2 followed by 5 days of rest and repeated weekly (2 days on and 5 days off treatment) in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.
Number of Participants With Reporting One or More Treatment-emergent Adverse Events (TEAEs)	3 Participants	6 Participants	3 Participants	3 Participants	16 Participants	3 Participants	3 Participants	9 Participants	6 Participants	6 Participants	5 Participants	6 Participants	6 Participants	4 Participants

SECONDARY outcome

Timeframe: Cycle 1 Day 1: pre-dose and 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-dose (Cycle length= 21 days [Schedules A, D and E] and 28 days [Schedule B])

Population: The pharmacokinetic (PK) population was defined as all participants for whom there were sufficient dosing and TAK-931 concentration-time data to reliably estimate the PK parameter(s). Here "overall number of participants analyzed" are participants who were available for this outcome measure assessment at given time period.

Outcome measures

Outcome measures
Measure	Schedule E: TAK-931 120 mg n=3 Participants TAK-931 120 mg, capsule, orally, once daily on Days 1 and 2 followed by 5 days of rest and repeated weekly (2 days on and 5 days off treatment) in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule E: TAK-931 150 mg n=6 Participants TAK-931 150 mg, capsule, orally, once daily on Days 1 and 2 followed by 5 days of rest and repeated weekly (2 days on and 5 days off treatment) in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule A: TAK-931 30 mg n=3 Participants TAK-931 30 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule A: TAK-931 40 mg n=3 Participants TAK-931 40 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule A: TAK-931 50 mg n=15 Participants TAK-931 50 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule A: TAK-931 60 mg n=3 Participants TAK-931 60 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule B: TAK-931 60 mg n=3 Participants TAK-931 60 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule B: TAK-931 80 mg n=9 Participants TAK-931 80 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule B: TAK-931 100 mg n=6 Participants TAK-931 100 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule B: TAK-931 120 mg n=6 Participants TAK-931 120 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule D: TAK-931 20 mg n=6 Participants TAK-931 20 mg, capsule, orally, once daily in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule D: TAK-931 30 mg n=6 Participants TAK-931 30 mg, capsule, orally, once daily in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule D: TAK-931 40 mg n=6 Participants TAK-931 40 mg, capsule, orally, once daily in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule E: TAK-931 100 mg n=4 Participants TAK-931 100 mg, capsule, orally, once daily on Days 1 and 2 followed by 5 days of rest and repeated weekly (2 days on and 5 days off treatment) in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.
Cmax: Maximum Observed Plasma Concentration After First Dose of TAK-931	514 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 15.9	499 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 23.3	133 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 22.6	229 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 14.3	214 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 40.9	265 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 9.8	277 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 19.0	302 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 31.7	402 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 24.5	454 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 49.2	98.3 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 37.0	149 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 39.8	197 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 31.5	462 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 36.1

SECONDARY outcome

Timeframe: Cycle 1 Day 1: pre-dose and 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-dose (Cycle length= 21 days [Schedules A, D and E] and 28 days [Schedule B])

Population: The PK population was defined as all participants for whom there were sufficient dosing and TAK-931 concentration-time data to reliably estimate the PK parameter(s). Here "overall number of participants analyzed" are participants who were available for this outcome measure assessment at given time period.

Outcome measures

Outcome measures
Measure	Schedule E: TAK-931 120 mg n=3 Participants TAK-931 120 mg, capsule, orally, once daily on Days 1 and 2 followed by 5 days of rest and repeated weekly (2 days on and 5 days off treatment) in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule E: TAK-931 150 mg n=6 Participants TAK-931 150 mg, capsule, orally, once daily on Days 1 and 2 followed by 5 days of rest and repeated weekly (2 days on and 5 days off treatment) in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule A: TAK-931 30 mg n=3 Participants TAK-931 30 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule A: TAK-931 40 mg n=3 Participants TAK-931 40 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule A: TAK-931 50 mg n=15 Participants TAK-931 50 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule A: TAK-931 60 mg n=3 Participants TAK-931 60 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule B: TAK-931 60 mg n=3 Participants TAK-931 60 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule B: TAK-931 80 mg n=9 Participants TAK-931 80 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule B: TAK-931 100 mg n=6 Participants TAK-931 100 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule B: TAK-931 120 mg n=6 Participants TAK-931 120 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule D: TAK-931 20 mg n=6 Participants TAK-931 20 mg, capsule, orally, once daily in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule D: TAK-931 30 mg n=6 Participants TAK-931 30 mg, capsule, orally, once daily in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule D: TAK-931 40 mg n=6 Participants TAK-931 40 mg, capsule, orally, once daily in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule E: TAK-931 100 mg n=4 Participants TAK-931 100 mg, capsule, orally, once daily on Days 1 and 2 followed by 5 days of rest and repeated weekly (2 days on and 5 days off treatment) in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) After First Dose of TAK-931	3.82 hours Interval 1.88 to 4.05	2.07 hours Interval 1.97 to 4.1	0.97 hours Interval 0.93 to 1.93	1.05 hours Interval 0.97 to 2.3	1.93 hours Interval 0.45 to 2.13	3.88 hours Interval 2.08 to 4.12	1.00 hours Interval 0.42 to 1.03	4.00 hours Interval 1.0 to 4.2	1.36 hours Interval 0.47 to 3.98	1.05 hours Interval 0.45 to 4.02	1.00 hours Interval 0.93 to 2.17	2.13 hours Interval 0.47 to 2.15	1.92 hours Interval 0.87 to 3.95	2.00 hours Interval 1.05 to 2.07

SECONDARY outcome

Timeframe: Cycle 1 Day 1: pre-dose and 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-dose (Cycle length= 21 days [Schedules A, D and E] and 28 days [Schedule B])

Outcome measures

Outcome measures
Measure	Schedule E: TAK-931 120 mg n=3 Participants TAK-931 120 mg, capsule, orally, once daily on Days 1 and 2 followed by 5 days of rest and repeated weekly (2 days on and 5 days off treatment) in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule E: TAK-931 150 mg n=6 Participants TAK-931 150 mg, capsule, orally, once daily on Days 1 and 2 followed by 5 days of rest and repeated weekly (2 days on and 5 days off treatment) in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule A: TAK-931 30 mg n=3 Participants TAK-931 30 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule A: TAK-931 40 mg n=3 Participants TAK-931 40 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule A: TAK-931 50 mg n=15 Participants TAK-931 50 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule A: TAK-931 60 mg n=3 Participants TAK-931 60 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule B: TAK-931 60 mg n=3 Participants TAK-931 60 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule B: TAK-931 80 mg n=9 Participants TAK-931 80 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule B: TAK-931 100 mg n=6 Participants TAK-931 100 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule B: TAK-931 120 mg n=6 Participants TAK-931 120 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule D: TAK-931 20 mg n=6 Participants TAK-931 20 mg, capsule, orally, once daily in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule D: TAK-931 30 mg n=6 Participants TAK-931 30 mg, capsule, orally, once daily in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule D: TAK-931 40 mg n=6 Participants TAK-931 40 mg, capsule, orally, once daily in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule E: TAK-931 100 mg n=4 Participants TAK-931 100 mg, capsule, orally, once daily on Days 1 and 2 followed by 5 days of rest and repeated weekly (2 days on and 5 days off treatment) in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.
AUC24: Area Under the Plasma Concentration-time Curve From 0 to 24 Hours After First Dose of TAK-931	3760 hournanogram per milliliter (hng/mL) Geometric Coefficient of Variation 48.9	3870 hournanogram per milliliter (hng/mL) Geometric Coefficient of Variation 35.9	737 hournanogram per milliliter (hng/mL) Geometric Coefficient of Variation 24.1	1250 hournanogram per milliliter (hng/mL) Geometric Coefficient of Variation 14.6	1240 hournanogram per milliliter (hng/mL) Geometric Coefficient of Variation 31.8	2000 hournanogram per milliliter (hng/mL) Geometric Coefficient of Variation 33.8	1470 hournanogram per milliliter (hng/mL) Geometric Coefficient of Variation 17.9	2140 hournanogram per milliliter (hng/mL) Geometric Coefficient of Variation 35.9	2240 hournanogram per milliliter (hng/mL) Geometric Coefficient of Variation 23.9	2740 hournanogram per milliliter (hng/mL) Geometric Coefficient of Variation 29.5	494 hournanogram per milliliter (hng/mL) Geometric Coefficient of Variation 52.5	801 hournanogram per milliliter (hng/mL) Geometric Coefficient of Variation 32.3	1100 hournanogram per milliliter (hng/mL) Geometric Coefficient of Variation 28.2	2720 hournanogram per milliliter (hng/mL) Geometric Coefficient of Variation 20.0

SECONDARY outcome

Timeframe: Cycle 1 Day 1: pre-dose and 0.5, 1, 2, 4, 6, 8 and 12 hours post-dose (Cycle length= 21 days [Schedules A, D and E] and 28 days [Schedule B])

Outcome measures

Outcome measures
Measure	Schedule E: TAK-931 120 mg n=3 Participants TAK-931 120 mg, capsule, orally, once daily on Days 1 and 2 followed by 5 days of rest and repeated weekly (2 days on and 5 days off treatment) in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule E: TAK-931 150 mg n=6 Participants TAK-931 150 mg, capsule, orally, once daily on Days 1 and 2 followed by 5 days of rest and repeated weekly (2 days on and 5 days off treatment) in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule A: TAK-931 30 mg n=3 Participants TAK-931 30 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule A: TAK-931 40 mg n=3 Participants TAK-931 40 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule A: TAK-931 50 mg n=15 Participants TAK-931 50 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule A: TAK-931 60 mg n=3 Participants TAK-931 60 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule B: TAK-931 60 mg n=3 Participants TAK-931 60 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule B: TAK-931 80 mg n=9 Participants TAK-931 80 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule B: TAK-931 100 mg n=6 Participants TAK-931 100 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule B: TAK-931 120 mg n=6 Participants TAK-931 120 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule D: TAK-931 20 mg n=6 Participants TAK-931 20 mg, capsule, orally, once daily in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule D: TAK-931 30 mg n=6 Participants TAK-931 30 mg, capsule, orally, once daily in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule D: TAK-931 40 mg n=6 Participants TAK-931 40 mg, capsule, orally, once daily in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule E: TAK-931 100 mg n=4 Participants TAK-931 100 mg, capsule, orally, once daily on Days 1 and 2 followed by 5 days of rest and repeated weekly (2 days on and 5 days off treatment) in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.
AUC12: Area Under the Plasma Concentration-time Curve From 0 to 12 Hours After Multiple Doses of TAK-931	3110 h*ng/mL Geometric Coefficient of Variation 42.8	3160 h*ng/mL Geometric Coefficient of Variation 30.3	641 h*ng/mL Geometric Coefficient of Variation 22.2	1110 h*ng/mL Geometric Coefficient of Variation 13.4	1070 h*ng/mL Geometric Coefficient of Variation 29.9	1670 h*ng/mL Geometric Coefficient of Variation 30.5	1270 h*ng/mL Geometric Coefficient of Variation 12.2	1800 h*ng/mL Geometric Coefficient of Variation 32.8	1970 h*ng/mL Geometric Coefficient of Variation 23.2	2360 h*ng/mL Geometric Coefficient of Variation 28.8	431 h*ng/mL Geometric Coefficient of Variation 49.9	693 h*ng/mL Geometric Coefficient of Variation 30.3	956 h*ng/mL Geometric Coefficient of Variation 27.0	2280 h*ng/mL Geometric Coefficient of Variation 23.8

SECONDARY outcome

Timeframe: Cycle 1 Day 1: pre-dose and 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-dose (Cycle length= 21 days [Schedules A, D and E] and 28 days [Schedule B])

Outcome measures

Outcome measures
Measure	Schedule E: TAK-931 120 mg n=3 Participants TAK-931 120 mg, capsule, orally, once daily on Days 1 and 2 followed by 5 days of rest and repeated weekly (2 days on and 5 days off treatment) in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule E: TAK-931 150 mg n=6 Participants TAK-931 150 mg, capsule, orally, once daily on Days 1 and 2 followed by 5 days of rest and repeated weekly (2 days on and 5 days off treatment) in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule A: TAK-931 30 mg n=3 Participants TAK-931 30 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule A: TAK-931 40 mg n=3 Participants TAK-931 40 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule A: TAK-931 50 mg n=15 Participants TAK-931 50 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule A: TAK-931 60 mg n=3 Participants TAK-931 60 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule B: TAK-931 60 mg n=3 Participants TAK-931 60 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule B: TAK-931 80 mg n=9 Participants TAK-931 80 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule B: TAK-931 100 mg n=6 Participants TAK-931 100 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule B: TAK-931 120 mg n=6 Participants TAK-931 120 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule D: TAK-931 20 mg n=6 Participants TAK-931 20 mg, capsule, orally, once daily in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule D: TAK-931 30 mg n=6 Participants TAK-931 30 mg, capsule, orally, once daily in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule D: TAK-931 40 mg n=6 Participants TAK-931 40 mg, capsule, orally, once daily in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule E: TAK-931 100 mg n=4 Participants TAK-931 100 mg, capsule, orally, once daily on Days 1 and 2 followed by 5 days of rest and repeated weekly (2 days on and 5 days off treatment) in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration After First Dose of TAK-931	3770 h*ng/mL Geometric Coefficient of Variation 49.3	3880 h*ng/mL Geometric Coefficient of Variation 35.8	742 h*ng/mL Geometric Coefficient of Variation 24.3	1250 h*ng/mL Geometric Coefficient of Variation 14.7	1250 h*ng/mL Geometric Coefficient of Variation 32.0	2010 h*ng/mL Geometric Coefficient of Variation 34.0	1480 h*ng/mL Geometric Coefficient of Variation 17.7	2160 h*ng/mL Geometric Coefficient of Variation 36.0	2240 h*ng/mL Geometric Coefficient of Variation 23.7	2750 h*ng/mL Geometric Coefficient of Variation 29.5	491 h*ng/mL Geometric Coefficient of Variation 53.3	805 h*ng/mL Geometric Coefficient of Variation 32.4	1100 h*ng/mL Geometric Coefficient of Variation 28.2	2730 h*ng/mL Geometric Coefficient of Variation 20.5

SECONDARY outcome

Timeframe: Cycle 1 Day 8 (Schedule A and D), Cycle 1 Day 7 (Schedule B), Cycle 1 Day 9 (Schedule E): pre-dose and 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-dose (Cycle length= 21 days [Schedules A, D and E] and 28 days [Schedule B])

Outcome measures

Outcome measures
Measure	Schedule E: TAK-931 120 mg n=3 Participants TAK-931 120 mg, capsule, orally, once daily on Days 1 and 2 followed by 5 days of rest and repeated weekly (2 days on and 5 days off treatment) in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule E: TAK-931 150 mg n=6 Participants TAK-931 150 mg, capsule, orally, once daily on Days 1 and 2 followed by 5 days of rest and repeated weekly (2 days on and 5 days off treatment) in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule A: TAK-931 30 mg n=3 Participants TAK-931 30 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule A: TAK-931 40 mg n=3 Participants TAK-931 40 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule A: TAK-931 50 mg n=15 Participants TAK-931 50 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule A: TAK-931 60 mg n=3 Participants TAK-931 60 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule B: TAK-931 60 mg n=3 Participants TAK-931 60 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule B: TAK-931 80 mg n=9 Participants TAK-931 80 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule B: TAK-931 100 mg n=6 Participants TAK-931 100 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule B: TAK-931 120 mg n=6 Participants TAK-931 120 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule D: TAK-931 20 mg n=6 Participants TAK-931 20 mg, capsule, orally, once daily in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule D: TAK-931 30 mg n=6 Participants TAK-931 30 mg, capsule, orally, once daily in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule D: TAK-931 40 mg n=6 Participants TAK-931 40 mg, capsule, orally, once daily in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule E: TAK-931 100 mg n=4 Participants TAK-931 100 mg, capsule, orally, once daily on Days 1 and 2 followed by 5 days of rest and repeated weekly (2 days on and 5 days off treatment) in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.
Cmax: Maximum Observed Plasma Concentration After Multiple Doses of TAK-931	654 ng/mL Geometric Coefficient of Variation 40.7	917 ng/mL Geometric Coefficient of Variation 22.1	133 ng/mL Geometric Coefficient of Variation 21.8	239 ng/mL Geometric Coefficient of Variation 16.2	231 ng/mL Geometric Coefficient of Variation 28.7	330 ng/mL Geometric Coefficient of Variation 23.9	218 ng/mL Geometric Coefficient of Variation 4.4	341 ng/mL Geometric Coefficient of Variation 54.0	380 ng/mL Geometric Coefficient of Variation 15.6	671 ng/mL Geometric Coefficient of Variation 73.6	104 ng/mL Geometric Coefficient of Variation 53.4	160 ng/mL Geometric Coefficient of Variation 34.1	193 ng/mL Geometric Coefficient of Variation 20.7	532 ng/mL Geometric Coefficient of Variation 39.9

SECONDARY outcome

Outcome measures

Outcome measures
Measure	Schedule E: TAK-931 120 mg n=3 Participants TAK-931 120 mg, capsule, orally, once daily on Days 1 and 2 followed by 5 days of rest and repeated weekly (2 days on and 5 days off treatment) in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule E: TAK-931 150 mg n=6 Participants TAK-931 150 mg, capsule, orally, once daily on Days 1 and 2 followed by 5 days of rest and repeated weekly (2 days on and 5 days off treatment) in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule A: TAK-931 30 mg n=3 Participants TAK-931 30 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule A: TAK-931 40 mg n=3 Participants TAK-931 40 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule A: TAK-931 50 mg n=14 Participants TAK-931 50 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule A: TAK-931 60 mg n=3 Participants TAK-931 60 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule B: TAK-931 60 mg n=3 Participants TAK-931 60 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule B: TAK-931 80 mg n=8 Participants TAK-931 80 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule B: TAK-931 100 mg n=6 Participants TAK-931 100 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule B: TAK-931 120 mg n=6 Participants TAK-931 120 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule D: TAK-931 20 mg n=6 Participants TAK-931 20 mg, capsule, orally, once daily in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule D: TAK-931 30 mg n=6 Participants TAK-931 30 mg, capsule, orally, once daily in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule D: TAK-931 40 mg n=5 Participants TAK-931 40 mg, capsule, orally, once daily in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule E: TAK-931 100 mg n=4 Participants TAK-931 100 mg, capsule, orally, once daily on Days 1 and 2 followed by 5 days of rest and repeated weekly (2 days on and 5 days off treatment) in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) After Multiple Doses of TAK-931	2.07 hours Interval 1.9 to 2.18	2.08 hours Interval 0.92 to 2.2	2.02 hours Interval 0.43 to 2.07	1.00 hours Interval 0.93 to 1.9	1.91 hours Interval 0.95 to 3.88	1.95 hours Interval 0.92 to 2.08	2.00 hours Interval 0.5 to 2.17	2.01 hours Interval 0.9 to 3.9	1.90 hours Interval 1.0 to 4.12	1.92 hours Interval 0.98 to 4.12	1.50 hours Interval 0.97 to 2.02	2.00 hours Interval 0.9 to 3.97	1.08 hours Interval 0.92 to 2.13	1.49 hours Interval 0.95 to 4.07

SECONDARY outcome

Outcome measures

Outcome measures
Measure	Schedule E: TAK-931 120 mg n=3 Participants TAK-931 120 mg, capsule, orally, once daily on Days 1 and 2 followed by 5 days of rest and repeated weekly (2 days on and 5 days off treatment) in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule E: TAK-931 150 mg n=6 Participants TAK-931 150 mg, capsule, orally, once daily on Days 1 and 2 followed by 5 days of rest and repeated weekly (2 days on and 5 days off treatment) in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule A: TAK-931 30 mg n=3 Participants TAK-931 30 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule A: TAK-931 40 mg n=3 Participants TAK-931 40 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule A: TAK-931 50 mg n=14 Participants TAK-931 50 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule A: TAK-931 60 mg n=3 Participants TAK-931 60 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule B: TAK-931 60 mg n=3 Participants TAK-931 60 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule B: TAK-931 80 mg n=8 Participants TAK-931 80 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule B: TAK-931 100 mg n=6 Participants TAK-931 100 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule B: TAK-931 120 mg n=6 Participants TAK-931 120 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule D: TAK-931 20 mg n=6 Participants TAK-931 20 mg, capsule, orally, once daily in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule D: TAK-931 30 mg n=6 Participants TAK-931 30 mg, capsule, orally, once daily in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule D: TAK-931 40 mg n=5 Participants TAK-931 40 mg, capsule, orally, once daily in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule E: TAK-931 100 mg n=4 Participants TAK-931 100 mg, capsule, orally, once daily on Days 1 and 2 followed by 5 days of rest and repeated weekly (2 days on and 5 days off treatment) in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.
AUC24: Area Under the Plasma Concentration-time Curve From 0 to 24 Hours After Multiple Doses of TAK-931	4830 h*ng/mL Geometric Coefficient of Variation 55.6	6260 h*ng/mL Geometric Coefficient of Variation 32.2	799 h*ng/mL Geometric Coefficient of Variation 19.3	1400 h*ng/mL Geometric Coefficient of Variation 15.4	1320 h*ng/mL Geometric Coefficient of Variation 33.6	2210 h*ng/mL Geometric Coefficient of Variation 30.5	1650 h*ng/mL Geometric Coefficient of Variation 10.4	2220 h*ng/mL Geometric Coefficient of Variation 39.8	2620 h*ng/mL Geometric Coefficient of Variation 26.8	4410 h*ng/mL Geometric Coefficient of Variation 81.8	600 h*ng/mL Geometric Coefficient of Variation 49.1	958 h*ng/mL Geometric Coefficient of Variation 46.1	1140 h*ng/mL Geometric Coefficient of Variation 41.2	3760 h*ng/mL Geometric Coefficient of Variation 28.6

SECONDARY outcome

Outcome measures

Outcome measures
Measure	Schedule E: TAK-931 120 mg n=3 Participants TAK-931 120 mg, capsule, orally, once daily on Days 1 and 2 followed by 5 days of rest and repeated weekly (2 days on and 5 days off treatment) in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule E: TAK-931 150 mg n=6 Participants TAK-931 150 mg, capsule, orally, once daily on Days 1 and 2 followed by 5 days of rest and repeated weekly (2 days on and 5 days off treatment) in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule A: TAK-931 30 mg n=3 Participants TAK-931 30 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule A: TAK-931 40 mg n=3 Participants TAK-931 40 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule A: TAK-931 50 mg n=14 Participants TAK-931 50 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule A: TAK-931 60 mg n=3 Participants TAK-931 60 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule B: TAK-931 60 mg n=3 Participants TAK-931 60 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule B: TAK-931 80 mg n=8 Participants TAK-931 80 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule B: TAK-931 100 mg n=6 Participants TAK-931 100 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule B: TAK-931 120 mg n=6 Participants TAK-931 120 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule D: TAK-931 20 mg n=6 Participants TAK-931 20 mg, capsule, orally, once daily in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule D: TAK-931 30 mg n=6 Participants TAK-931 30 mg, capsule, orally, once daily in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule D: TAK-931 40 mg n=5 Participants TAK-931 40 mg, capsule, orally, once daily in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule E: TAK-931 100 mg n=4 Participants TAK-931 100 mg, capsule, orally, once daily on Days 1 and 2 followed by 5 days of rest and repeated weekly (2 days on and 5 days off treatment) in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration After Multiple Doses of TAK-931	4840 h*ng/mL Geometric Coefficient of Variation 55.8	6280 h*ng/mL Geometric Coefficient of Variation 32.2	805 h*ng/mL Geometric Coefficient of Variation 19.4	1410 h*ng/mL Geometric Coefficient of Variation 15.0	1330 h*ng/mL Geometric Coefficient of Variation 33.9	2220 h*ng/mL Geometric Coefficient of Variation 30.8	1650 h*ng/mL Geometric Coefficient of Variation 10.4	2230 h*ng/mL Geometric Coefficient of Variation 39.8	2630 h*ng/mL Geometric Coefficient of Variation 27.4	4420 h*ng/mL Geometric Coefficient of Variation 81.0	603 h*ng/mL Geometric Coefficient of Variation 49.2	964 h*ng/mL Geometric Coefficient of Variation 46.4	1150 h*ng/mL Geometric Coefficient of Variation 41.3	3770 h*ng/mL Geometric Coefficient of Variation 28.7

SECONDARY outcome

Timeframe: Cycle 1 Day 1 pre-dose up to any dosing day after 3 consecutive days post-dose (up to Cycle 1 Day 8 [Schedule A and D]; Cycle 1 Day 7 [Schedule B]; Cycle 1 Day 12 [Schedule D]) (Cycle Length of Schedules A and D = 21 days; and Schedule B= 28 days)

Population: Pharmacodynamics population: all participants who received at least the first dose of TAK-931, had a baseline skin punch biopsy sample, and had at least 1 additional postbaseline skin punch biopsy sample. Overall number analyzed "N": participants who were evaluable for the outcome measure. Number analyzed "n": participants who were evaluable for this outcome measure for given categories. Data for this outcome measure was not collected and analyzed for Schedule E Cohorts due to business reasons.

H-score were a composite score that comprised of intensity and percentage of staining and were used for assessing amount of protein (in this case pMCM2 \[Ser40\]) present in a tissue sample. The composite score obtained by H-score is derived by adding of the percentages of cell staining at each intensity level multiplied by the weighted intensity of staining (0 \[no staining\], 1+ \[weak staining\], 2+ \[medium staining\], 3+ \[strong staining\]). The H-score has a range of 0 to 300. Lower H-scores represent lower expression of pMCM2 (Ser40) in the tissue sample, while higher scores represent stronger expression of pMCM2 (Ser40) in the tissue samples.

Outcome measures

Outcome measures
Measure	Schedule E: TAK-931 120 mg TAK-931 120 mg, capsule, orally, once daily on Days 1 and 2 followed by 5 days of rest and repeated weekly (2 days on and 5 days off treatment) in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule E: TAK-931 150 mg TAK-931 150 mg, capsule, orally, once daily on Days 1 and 2 followed by 5 days of rest and repeated weekly (2 days on and 5 days off treatment) in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule A: TAK-931 30 mg n=3 Participants TAK-931 30 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule A: TAK-931 40 mg n=3 Participants TAK-931 40 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule A: TAK-931 50 mg n=16 Participants TAK-931 50 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule A: TAK-931 60 mg n=3 Participants TAK-931 60 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule B: TAK-931 60 mg n=3 Participants TAK-931 60 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule B: TAK-931 80 mg n=9 Participants TAK-931 80 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule B: TAK-931 100 mg TAK-931 100 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule B: TAK-931 120 mg TAK-931 120 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule D: TAK-931 20 mg n=6 Participants TAK-931 20 mg, capsule, orally, once daily in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule D: TAK-931 30 mg n=6 Participants TAK-931 30 mg, capsule, orally, once daily in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule D: TAK-931 40 mg TAK-931 40 mg, capsule, orally, once daily in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule E: TAK-931 100 mg TAK-931 100 mg, capsule, orally, once daily on Days 1 and 2 followed by 5 days of rest and repeated weekly (2 days on and 5 days off treatment) in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.
Schedule A, B and D: Change From Baseline in Phosphorylated Minichromosome Maintenance Complex-2 (pMCM2) (Ser40) Levels in Skin Based on Histological Score Nuclei (H-score) After Multiple Doses Of TAK-931 Baseline	—	—	18.467 score on a scale Standard Deviation 8.4506	19.533 score on a scale Standard Deviation 3.7754	10.500 score on a scale Standard Deviation 5.8477	10.933 score on a scale Standard Deviation 1.9425	4.400 score on a scale Standard Deviation 2.9597	12.720 score on a scale Standard Deviation 2.0229	—	—	22.050 score on a scale Standard Deviation 24.5239	33.317 score on a scale Standard Deviation 23.4266	—	—
Schedule A, B and D: Change From Baseline in Phosphorylated Minichromosome Maintenance Complex-2 (pMCM2) (Ser40) Levels in Skin Based on Histological Score Nuclei (H-score) After Multiple Doses Of TAK-931 Schedule B: Change at Cycle 1 Day 7	—	—	—	—	—	—	-3.733 score on a scale Standard Deviation 3.1770	-9.180 score on a scale Standard Deviation 7.2589	—	—	—	—	—	—
Schedule A, B and D: Change From Baseline in Phosphorylated Minichromosome Maintenance Complex-2 (pMCM2) (Ser40) Levels in Skin Based on Histological Score Nuclei (H-score) After Multiple Doses Of TAK-931 Schedule A and D: Change at Cycle 1 Day 8	—	—	-7.533 score on a scale Standard Deviation 2.9280	-6.667 score on a scale Standard Deviation 10.5078	-6.743 score on a scale Standard Deviation 8.7444	-9.933 score on a scale Standard Deviation 2.2030	—	—	—	—	-5.900 score on a scale Standard Deviation 4.2379	-26.883 score on a scale Standard Deviation 24.5978	—	—
Schedule A, B and D: Change From Baseline in Phosphorylated Minichromosome Maintenance Complex-2 (pMCM2) (Ser40) Levels in Skin Based on Histological Score Nuclei (H-score) After Multiple Doses Of TAK-931 Schedule D: Change at Cycle 1 Day 12	—	—	—	—	—	—	—	—	—	—	-67.100 score on a scale	—	—	—

SECONDARY outcome

Positive index was calculated by taking the number of cells staining positive for the marker over the total number of cells.

Outcome measures

Outcome measures
Measure	Schedule E: TAK-931 120 mg TAK-931 120 mg, capsule, orally, once daily on Days 1 and 2 followed by 5 days of rest and repeated weekly (2 days on and 5 days off treatment) in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule E: TAK-931 150 mg TAK-931 150 mg, capsule, orally, once daily on Days 1 and 2 followed by 5 days of rest and repeated weekly (2 days on and 5 days off treatment) in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule A: TAK-931 30 mg n=3 Participants TAK-931 30 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule A: TAK-931 40 mg n=3 Participants TAK-931 40 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule A: TAK-931 50 mg n=16 Participants TAK-931 50 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule A: TAK-931 60 mg n=3 Participants TAK-931 60 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule B: TAK-931 60 mg n=3 Participants TAK-931 60 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule B: TAK-931 80 mg n=9 Participants TAK-931 80 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule B: TAK-931 100 mg TAK-931 100 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule B: TAK-931 120 mg TAK-931 120 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule D: TAK-931 20 mg n=6 Participants TAK-931 20 mg, capsule, orally, once daily in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule D: TAK-931 30 mg n=6 Participants TAK-931 30 mg, capsule, orally, once daily in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule D: TAK-931 40 mg TAK-931 40 mg, capsule, orally, once daily in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule E: TAK-931 100 mg TAK-931 100 mg, capsule, orally, once daily on Days 1 and 2 followed by 5 days of rest and repeated weekly (2 days on and 5 days off treatment) in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.
Schedule A, B and D: Change From Baseline in pMCM2 (Ser40) Levels in Skin Based on Positive Index After Multiple Doses Of TAK-931 Baseline	—	—	0.08600 percentage of cell Standard Deviation 0.039950	0.08533 percentage of cell Standard Deviation 0.019425	0.04429 percentage of cell Standard Deviation 0.021780	0.04800 percentage of cell Standard Deviation 0.006928	0.02000 percentage of cell Standard Deviation 0.013856	0.05080 percentage of cell Standard Deviation 0.007694	—	—	0.10217 percentage of cell Standard Deviation 0.126757	0.15200 percentage of cell Standard Deviation 0.128829	—	—
Schedule A, B and D: Change From Baseline in pMCM2 (Ser40) Levels in Skin Based on Positive Index After Multiple Doses Of TAK-931 Schedule B: Change at Cycle 1 Day 7	—	—	—	—	—	—	-0.01667 percentage of cell Standard Deviation 0.015144	-0.01916 percentage of cell Standard Deviation 0.063995	—	—	—	—	—	—
Schedule A, B and D: Change From Baseline in pMCM2 (Ser40) Levels in Skin Based on Positive Index After Multiple Doses Of TAK-931 Schedule A and D: Change at Cycle 1 Day 8	—	—	-0.03037 percentage of cell Standard Deviation 0.014191	-0.02386 percentage of cell Standard Deviation 0.046889	-0.02643 percentage of cell Standard Deviation 0.033014	-0.04125 percentage of cell Standard Deviation 0.008245	—	—	—	—	-0.02150 percentage of cell Standard Deviation 0.018930	-0.12436 percentage of cell Standard Deviation 0.134410	—	—
Schedule A, B and D: Change From Baseline in pMCM2 (Ser40) Levels in Skin Based on Positive Index After Multiple Doses Of TAK-931 Schedule D: Change at Cycle 1 Day 12	—	—	—	—	—	—	—	—	—	—	-0.33900 percentage of cell	—	—	—

SECONDARY outcome

Timeframe: From date of first dose to the date of first documentation of progressive disease (PD) or death due to any cause, which ever occurred first (up to Month 45)

Population: The response-evaluable population is defined as participants who receive at least 1 dose of study drug, have measurable disease at baseline, and at least 1 post-baseline response assessment. Here "overall number of participants analyzed" are participants who were available for this outcome measure assessment at given time period.

ORR was defined as percentage of participants who had achieved complete response (CR) and partial response (PR), as measured by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST V 1.1). CR: was disappearance of all target lesions. Any pathological lymph nodes (target or non-target) had to be reduced in short axis to less than (\<) 10 millimeter (mm). PR: was at least a 30 percent (%) decrease in sum of diameter (SOD) of target lesions, taking as reference the baseline SOD.

Outcome measures

Outcome measures
Measure	Schedule E: TAK-931 120 mg n=3 Participants TAK-931 120 mg, capsule, orally, once daily on Days 1 and 2 followed by 5 days of rest and repeated weekly (2 days on and 5 days off treatment) in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule E: TAK-931 150 mg n=5 Participants TAK-931 150 mg, capsule, orally, once daily on Days 1 and 2 followed by 5 days of rest and repeated weekly (2 days on and 5 days off treatment) in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule A: TAK-931 30 mg n=3 Participants TAK-931 30 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule A: TAK-931 40 mg n=3 Participants TAK-931 40 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule A: TAK-931 50 mg n=15 Participants TAK-931 50 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule A: TAK-931 60 mg n=3 Participants TAK-931 60 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule B: TAK-931 60 mg n=3 Participants TAK-931 60 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule B: TAK-931 80 mg n=8 Participants TAK-931 80 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule B: TAK-931 100 mg n=6 Participants TAK-931 100 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule B: TAK-931 120 mg n=6 Participants TAK-931 120 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule D: TAK-931 20 mg n=6 Participants TAK-931 20 mg, capsule, orally, once daily in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule D: TAK-931 30 mg n=5 Participants TAK-931 30 mg, capsule, orally, once daily in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule D: TAK-931 40 mg n=6 Participants TAK-931 40 mg, capsule, orally, once daily in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule E: TAK-931 100 mg n=3 Participants TAK-931 100 mg, capsule, orally, once daily on Days 1 and 2 followed by 5 days of rest and repeated weekly (2 days on and 5 days off treatment) in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.
Overall Response Rate (ORR)	0 percentage of participants Interval 0.0 to 71.0	0 percentage of participants Interval 0.0 to 52.0	33 percentage of participants Interval 1.0 to 91.0	0 percentage of participants Interval 0.0 to 71.0	7 percentage of participants Interval 0.0 to 32.0	33 percentage of participants Interval 1.0 to 91.0	0 percentage of participants Interval 0.0 to 71.0	0 percentage of participants Interval 0.0 to 37.0	17 percentage of participants Interval 0.0 to 64.0	17 percentage of participants Interval 0.0 to 64.0	0 percentage of participants Interval 0.0 to 46.0	0 percentage of participants Interval 0.0 to 52.0	0 percentage of participants Interval 0.0 to 46.0	0 percentage of participants Interval 0.0 to 71.0

SECONDARY outcome

Timeframe: From date of first dose to the date of first documentation of PD or death due to any cause, which ever occurred first (up to Month 45)

Population: The safety population was defined as all participants who received any amount of study drug.

PFS was defined as the time from the date of first dose to the date of first documentation of PD or death due to any cause, whichever occurs first, as measured by RECIST V1.1. PD: 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PFS was analyzed using the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Schedule E: TAK-931 120 mg n=3 Participants TAK-931 120 mg, capsule, orally, once daily on Days 1 and 2 followed by 5 days of rest and repeated weekly (2 days on and 5 days off treatment) in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule E: TAK-931 150 mg n=6 Participants TAK-931 150 mg, capsule, orally, once daily on Days 1 and 2 followed by 5 days of rest and repeated weekly (2 days on and 5 days off treatment) in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule A: TAK-931 30 mg n=3 Participants TAK-931 30 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule A: TAK-931 40 mg n=3 Participants TAK-931 40 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule A: TAK-931 50 mg n=16 Participants TAK-931 50 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule A: TAK-931 60 mg n=3 Participants TAK-931 60 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule B: TAK-931 60 mg n=3 Participants TAK-931 60 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule B: TAK-931 80 mg n=9 Participants TAK-931 80 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule B: TAK-931 100 mg n=6 Participants TAK-931 100 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule B: TAK-931 120 mg n=6 Participants TAK-931 120 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule D: TAK-931 20 mg n=6 Participants TAK-931 20 mg, capsule, orally, once daily in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule D: TAK-931 30 mg n=6 Participants TAK-931 30 mg, capsule, orally, once daily in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule D: TAK-931 40 mg n=6 Participants TAK-931 40 mg, capsule, orally, once daily in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule E: TAK-931 100 mg n=4 Participants TAK-931 100 mg, capsule, orally, once daily on Days 1 and 2 followed by 5 days of rest and repeated weekly (2 days on and 5 days off treatment) in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.
Progression-free Survival (PFS)	1.9 months Interval 1.05 to 4.37	2.6 months Interval 0.53 to 5.88	4.2 months Interval 1.74 to 9.2	2.1 months Interval 0.53 to 3.29	2.0 months Interval 1.68 to 5.32	4.8 months Interval 3.32 to 6.34	3.1 months Interval 0.92 to 5.85	2.8 months Interval 1.58 to 3.25	2.1 months Interval 0.79 to 6.21	4.2 months Interval 1.84 to 6.64	1.9 months Interval 1.41 to 2.1	3.9 months Interval 1.91 to 8.05	2.1 months Interval 1.18 to 15.24	1.9 months Interval 0.39 to 3.91

SECONDARY outcome

Timeframe: From the date of first documentation of response to the date of first documentation of PD (up to Month 45)

Population: The response-evaluable population is defined as participants who receive at least 1 dose of study drug, have measurable disease at baseline, and at least 1 post-baseline response assessment. Responders without documentation of PD were censored at the date of last response assessment that is stable disease or better.

The DOR was defined as the time from the date of first documentation of a response (CR or PR) to the date of first documentation of PD, as measured by RECIST V 1.1. CR: was disappearance of all target lesions. Any pathological lymph nodes (target or non-target) had to be reduced in short axis to \<10 mm. PR: was at least a 30% decrease in SOD of target lesions, taking as reference the baseline SOD. PD: 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. DOR was analyzed using the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Schedule E: TAK-931 120 mg TAK-931 120 mg, capsule, orally, once daily on Days 1 and 2 followed by 5 days of rest and repeated weekly (2 days on and 5 days off treatment) in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule E: TAK-931 150 mg TAK-931 150 mg, capsule, orally, once daily on Days 1 and 2 followed by 5 days of rest and repeated weekly (2 days on and 5 days off treatment) in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule A: TAK-931 30 mg n=1 Participants TAK-931 30 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule A: TAK-931 40 mg TAK-931 40 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule A: TAK-931 50 mg n=1 Participants TAK-931 50 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule A: TAK-931 60 mg n=1 Participants TAK-931 60 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule B: TAK-931 60 mg TAK-931 60 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule B: TAK-931 80 mg TAK-931 80 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule B: TAK-931 100 mg n=1 Participants TAK-931 100 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule B: TAK-931 120 mg n=1 Participants TAK-931 120 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule D: TAK-931 20 mg TAK-931 20 mg, capsule, orally, once daily in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule D: TAK-931 30 mg TAK-931 30 mg, capsule, orally, once daily in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule D: TAK-931 40 mg TAK-931 40 mg, capsule, orally, once daily in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule E: TAK-931 100 mg TAK-931 100 mg, capsule, orally, once daily on Days 1 and 2 followed by 5 days of rest and repeated weekly (2 days on and 5 days off treatment) in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.
Duration of Response (DOR)	—	—	2.1 months	—	2.7 months	2.2 months	—	—	4.2 months	0.0 months	—	—	—	—

Adverse Events

Schedule A: TAK-931 30 mg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Schedule A: TAK-931 40 mg

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Schedule A: TAK-931 50 mg

Serious events: 5 serious events

Other events: 16 other events

Deaths: 0 deaths

Schedule A: TAK-931 60 mg

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Schedule B: TAK-931 60 mg

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Schedule B: TAK-931 80 mg

Serious events: 2 serious events

Other events: 9 other events

Deaths: 0 deaths

Schedule B: TAK-931 100 mg

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Schedule B: TAK-931 120 mg

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Schedule D: TAK-931 20 mg

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Schedule D: TAK-931 30 mg

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Schedule D: TAK-931 40 mg

Serious events: 3 serious events

Other events: 6 other events

Deaths: 0 deaths

Schedule E: TAK-931 100 mg

Serious events: 2 serious events

Other events: 4 other events

Deaths: 0 deaths

Schedule E: TAK-931 120 mg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Schedule E: TAK-931 150 mg

Serious events: 3 serious events

Other events: 6 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Schedule A: TAK-931 30 mg n=3 participants at risk TAK-931 30 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule A: TAK-931 40 mg n=3 participants at risk TAK-931 40 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule A: TAK-931 50 mg n=16 participants at risk TAK-931 50 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule A: TAK-931 60 mg n=3 participants at risk TAK-931 60 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule B: TAK-931 60 mg n=3 participants at risk TAK-931 60 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule B: TAK-931 80 mg n=9 participants at risk TAK-931 80 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule B: TAK-931 100 mg n=6 participants at risk TAK-931 100 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule B: TAK-931 120 mg n=6 participants at risk TAK-931 120 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule D: TAK-931 20 mg n=6 participants at risk TAK-931 20 mg, capsule, orally, once daily in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule D: TAK-931 30 mg n=6 participants at risk TAK-931 30 mg, capsule, orally, once daily in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule D: TAK-931 40 mg n=6 participants at risk TAK-931 40 mg, capsule, orally, once daily in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule E: TAK-931 100 mg n=4 participants at risk TAK-931 100 mg, capsule, orally, once daily on Days 1 and 2 followed by 5 days of rest and repeated weekly (2 days on and 5 days off treatment) in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule E: TAK-931 120 mg n=3 participants at risk TAK-931 120 mg, capsule, orally, once daily on Days 1 and 2 followed by 5 days of rest and repeated weekly (2 days on and 5 days off treatment) in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule E: TAK-931 150 mg n=6 participants at risk TAK-931 150 mg, capsule, orally, once daily on Days 1 and 2 followed by 5 days of rest and repeated weekly (2 days on and 5 days off treatment) in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.
Infections and infestations Lower respiratory tract and lung infections	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oncologic complications and emergencies	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	12.5% 2/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	25.0% 1/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant ascites	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	12.5% 2/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant pleural effusion	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	25.0% 1/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mediastinal neoplasms malignant	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thymoma malignant	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to specified sites	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphangiosis carcinomatosa	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic neoplasms malignant (excl islet cell and carcinoid)	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Blood and lymphatic system disorders Neutropenias 0 1 (33) 0 1	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	22.2% 2/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	22.2% 2/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Blood and lymphatic system disorders Neutropenia	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Gastrointestinal stenosis and obstruction NEC	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	11.1% 1/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Ileus	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	11.1% 1/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Duodenal and small intestinal stenosis and obstruction	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Duodenal obstruction	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Gastrointestinal inflammatory disorders NEC	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Enterocolitis	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Nausea and vomiting symptoms	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Nausea	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Sepsis, bacteraemia, viraemia and fungaemia NEC	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Bacteraemia	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Sepsis	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Abdominal and gastrointestinal infections	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	11.1% 1/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Abdominal abscess	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	11.1% 1/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Pneumonia	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Appetite disorders	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Central nervous system haemorrhages and cerebrovascular accidents	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Cerebrovascular accident	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Increased intracranial pressure disorders	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	25.0% 1/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Brain oedema	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	25.0% 1/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Seizures and seizure disorders NEC	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	25.0% 1/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Seizure	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	25.0% 1/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Lower respiratory tract inflammatory and immunologic conditions	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Pneumothorax and pleural effusions NEC	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Asthenic conditions	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Malaise	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Renal and urinary disorders Urinary abnormalities	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Renal and urinary disorders Haematuria	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.

Other adverse events

Other adverse events
Measure	Schedule A: TAK-931 30 mg n=3 participants at risk TAK-931 30 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule A: TAK-931 40 mg n=3 participants at risk TAK-931 40 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule A: TAK-931 50 mg n=16 participants at risk TAK-931 50 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule A: TAK-931 60 mg n=3 participants at risk TAK-931 60 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule B: TAK-931 60 mg n=3 participants at risk TAK-931 60 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule B: TAK-931 80 mg n=9 participants at risk TAK-931 80 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule B: TAK-931 100 mg n=6 participants at risk TAK-931 100 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule B: TAK-931 120 mg n=6 participants at risk TAK-931 120 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule D: TAK-931 20 mg n=6 participants at risk TAK-931 20 mg, capsule, orally, once daily in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule D: TAK-931 30 mg n=6 participants at risk TAK-931 30 mg, capsule, orally, once daily in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule D: TAK-931 40 mg n=6 participants at risk TAK-931 40 mg, capsule, orally, once daily in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule E: TAK-931 100 mg n=4 participants at risk TAK-931 100 mg, capsule, orally, once daily on Days 1 and 2 followed by 5 days of rest and repeated weekly (2 days on and 5 days off treatment) in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule E: TAK-931 120 mg n=3 participants at risk TAK-931 120 mg, capsule, orally, once daily on Days 1 and 2 followed by 5 days of rest and repeated weekly (2 days on and 5 days off treatment) in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.	Schedule E: TAK-931 150 mg n=6 participants at risk TAK-931 150 mg, capsule, orally, once daily on Days 1 and 2 followed by 5 days of rest and repeated weekly (2 days on and 5 days off treatment) in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.
Gastrointestinal disorders Nausea	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	66.7% 2/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	62.5% 10/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 3/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 9/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	83.3% 5/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 6/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	50.0% 3/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 2/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	25.0% 1/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	66.7% 2/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	66.7% 4/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Blood and lymphatic system disorders Neutropenia	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	50.0% 8/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	66.7% 2/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	77.8% 7/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	83.3% 5/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 6/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 2/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	50.0% 3/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	25.0% 1/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	66.7% 2/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	83.3% 5/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Vomiting	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	25.0% 4/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	66.7% 2/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	77.8% 7/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 2/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	66.7% 4/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 2/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	25.0% 1/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	66.7% 2/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	66.7% 4/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations White blood cell count decreased	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	37.5% 6/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	11.1% 1/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	66.7% 4/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	50.0% 3/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	50.0% 3/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	25.0% 1/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	83.3% 5/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	18.8% 3/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	66.7% 2/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	55.6% 5/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	50.0% 3/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	66.7% 4/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 2/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	25.0% 1/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 2/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	25.0% 4/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	22.2% 2/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 2/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 2/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 2/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 2/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	66.7% 4/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Blood and lymphatic system disorders Anaemia	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	25.0% 4/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	11.1% 1/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 2/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 2/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	25.0% 1/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	66.7% 4/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Blood and lymphatic system disorders Leukopenia	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	18.8% 3/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	55.6% 5/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	83.3% 5/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 2/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Diarrhoea	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	31.2% 5/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	22.2% 2/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 2/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	50.0% 3/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Fatigue	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	66.7% 2/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	11.1% 1/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 2/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 2/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Vascular disorders Hypotension	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	22.2% 2/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 2/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	75.0% 3/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 2/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Constipation	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	22.2% 2/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 2/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Stomatitis	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 3/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Malaise	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	18.8% 3/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	11.1% 1/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Oedema peripheral	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	18.8% 3/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	66.7% 2/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Pyrexia	66.7% 2/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	18.8% 3/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 2/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	25.0% 1/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Blood creatinine increased	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	12.5% 2/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 2/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	50.0% 3/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	18.8% 3/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	11.1% 1/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Nasopharyngitis	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 3/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Platelet count decreased	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	12.5% 2/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	18.8% 3/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	66.7% 2/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 3/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Aspartate aminotransferase increased	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 2/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	25.0% 1/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Gamma-glutamyltransferase increased	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 2/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	25.0% 1/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Psychiatric disorders Insomnia	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 2/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	22.2% 2/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Ascites	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Rash papular	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	66.7% 2/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 2/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Blood bilirubin increased	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Cardiac disorders Electrocardiogram QT prolonged	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Injury, poisoning and procedural complications Fall	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Hypophosphataemia	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	11.1% 1/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Lymphocyte count decreased	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	18.8% 3/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Vascular disorders Orthostatic hypotension	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 2/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 2/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Alanine aminotransferase increased	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Cough	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	11.1% 1/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Rash erythematous	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Application site pruritus	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	66.7% 2/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Musculoskeletal and connective tissue disorders Back pain	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Hepatobiliary disorders Bile duct obstruction	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Blood alkaline phosphatase increased	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	25.0% 1/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Brain natriuretic peptide increased	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	11.1% 1/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	11.1% 1/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Dysgeusia	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	11.1% 1/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Vascular disorders Hypertension	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Hypocalcaemia	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	11.1% 1/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	11.1% 1/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Ileus	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	11.1% 1/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Vascular disorders Jugular vein thrombosis	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Pneumonia	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	22.2% 2/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Upper respiratory tract infection	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Urinary tract infection	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Ear and labyrinth disorders Vertigo	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Eye disorders Abnormal sensation in eye	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Alopecia areata	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Angular cheilitis	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Bronchitis bacterial	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Cardiac disorders Cardiomyopathy	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Eye disorders Cataract	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Hepatobiliary disorders Cholangitis	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Conjunctivitis	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Injury, poisoning and procedural complications Contusion	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Cystitis	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	11.1% 1/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Dementia	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Dermatitis bullous	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Eye disorders Dry eye	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Duodenal obstruction	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	11.1% 1/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Eye infection	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Lip dry	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Face oedema	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Gastritis	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Haemorrhoids	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Headache	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Hepatobiliary disorders Hepatomegaly	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Renal and urinary disorders Hydronephrosis	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Hypermagnesaemia	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Renal and urinary disorders Hypertonic bladder	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	11.1% 1/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Influenza like illness	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Infusion site extravasation	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Large intestinal haemorrhage	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Blood and lymphatic system disorders Lymphadenitis	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Vascular disorders Lymphoedema	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Miliaria	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Non-cardiac chest pain	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Oral candidiasis	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Oral herpes	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Pancreatitis	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Periodontitis	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Pharyngeal inflammation	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Vascular disorders Phlebitis	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Photosensitivity reaction	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Injury, poisoning and procedural complications Radiation skin injury	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Seizure	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Skin disorder	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Somnolence	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Cardiac disorders Stress cardiomyopathy	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	25.0% 1/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Cardiac disorders Supraventricular tachycardia	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Injury, poisoning and procedural complications Tooth fracture	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Tooth loss	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	25.0% 1/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Vagus nerve disorder	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	11.1% 1/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Vascular disorders Venous thrombosis	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Eye disorders Vision blurred	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Weight decreased	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Weight increased	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	11.1% 1/9 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug through 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (whichever occurred first) (up to Day 499) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.

Additional Information

Medical Director

Takeda

Phone: +1-877-825-3327

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.
Publication restrictions are in place

Restriction type: OTHER