Trial Outcomes & Findings for Safety Study of Enoblituzumab (MGA271) in Combination With Pembrolizumab or MGA012 in Refractory Cancer (NCT NCT02475213)

Last Updated: 2025-08-11

Results Overview

Dose-limiting toxicities are severe side effects related to study treatment that may cause dose interruptions, dose reductions, or withdrawal of treatment.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

146 participants

Primary outcome timeframe

Study Day 1-42, for Cohorts 1-4.

Results posted on

2025-08-11

Participant Flow

Participant milestones

Participant milestones
Measure	Cohort 1 enoblituzumab 3 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	Cohort 2 enoblituzumab 10 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	Cohort 3 enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	Melanoma Cohort enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	Urothelial Cancer Cohort enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	NSCLC Cohort enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	SCCHN Cohort enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	Cohort 4 enoblituzumab 15 mg/kg IV and retifanlimab 375 mg IV every 3 weeks for up to 17 doses.
Overall Study STARTED	6	3	3	17	21	40	44	12
Overall Study Safety Population	6	3	3	17	21	40	43	12
Overall Study PK Population	6	3	3	17	21	39	42	12
Overall Study Response Evaluable Population	6	3	3	15	17	34	35	11
Overall Study COMPLETED	0	0	0	1	1	3	1	0
Overall Study NOT COMPLETED	6	3	3	16	20	37	43	12

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1 enoblituzumab 3 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	Cohort 2 enoblituzumab 10 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	Cohort 3 enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	Melanoma Cohort enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	Urothelial Cancer Cohort enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	NSCLC Cohort enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	SCCHN Cohort enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	Cohort 4 enoblituzumab 15 mg/kg IV and retifanlimab 375 mg IV every 3 weeks for up to 17 doses.
Overall Study Adverse Event	2	0	0	1	1	4	6	2
Overall Study Physician Decision	1	1	1	0	0	1	4	0
Overall Study Progressive Disease	3	2	2	13	15	25	30	10
Overall Study Death	0	0	0	0	0	4	1	0
Overall Study Protocol Violation	0	0	0	0	1	0	0	0
Overall Study Withdrawal by Subject	0	0	0	1	0	2	2	0
Overall Study Other	0	0	0	1	3	1	0	0

Baseline Characteristics

Safety Study of Enoblituzumab (MGA271) in Combination With Pembrolizumab or MGA012 in Refractory Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1 n=6 Participants enoblituzumab 3 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	Cohort 2 n=3 Participants enoblituzumab 10 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	Cohort 3 n=3 Participants enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	Melanoma Expansion n=17 Participants enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	Urothelial Cancer Expansion n=21 Participants enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	NSCLC Expansion n=40 Participants enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	SCCHN Expansion n=43 Participants enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	Cohort 4 n=12 Participants enoblituzumab 15 mg/kg IV and retifanlimab 375 mg IV every three weeks for up to 17 doses..	Total n=145 Participants Total of all reporting groups
Age, Continuous	64.0 years STANDARD_DEVIATION 7.85 • n=5 Participants	41.7 years STANDARD_DEVIATION 25.38 • n=7 Participants	74.7 years STANDARD_DEVIATION 14.64 • n=5 Participants	62.9 years STANDARD_DEVIATION 14.92 • n=4 Participants	67.2 years STANDARD_DEVIATION 9.24 • n=21 Participants	64.8 years STANDARD_DEVIATION 8.20 • n=10 Participants	62.7 years STANDARD_DEVIATION 9.63 • n=115 Participants	62.4 years STANDARD_DEVIATION 12.09 • n=24 Participants	63.8 years STANDARD_DEVIATION 11.06 • n=42 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	6 Participants n=4 Participants	6 Participants n=21 Participants	18 Participants n=10 Participants	5 Participants n=115 Participants	6 Participants n=24 Participants	47 Participants n=42 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	11 Participants n=4 Participants	15 Participants n=21 Participants	22 Participants n=10 Participants	38 Participants n=115 Participants	6 Participants n=24 Participants	98 Participants n=42 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=10 Participants	2 Participants n=115 Participants	1 Participants n=24 Participants	6 Participants n=42 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	16 Participants n=4 Participants	21 Participants n=21 Participants	37 Participants n=10 Participants	41 Participants n=115 Participants	10 Participants n=24 Participants	136 Participants n=42 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants	0 Participants n=115 Participants	1 Participants n=24 Participants	3 Participants n=42 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	1 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants	0 Participants n=24 Participants	1 Participants n=42 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=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 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	1 Participants n=21 Participants	2 Participants n=10 Participants	6 Participants n=115 Participants	3 Participants n=24 Participants	12 Participants n=42 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	17 Participants n=4 Participants	19 Participants n=21 Participants	36 Participants n=10 Participants	34 Participants n=115 Participants	8 Participants n=24 Participants	126 Participants n=42 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=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 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	1 Participants n=21 Participants	1 Participants n=10 Participants	2 Participants n=115 Participants	1 Participants n=24 Participants	5 Participants n=42 Participants
Region of Enrollment United States	6 participants n=5 Participants	3 participants n=7 Participants	3 participants n=5 Participants	14 participants n=4 Participants	19 participants n=21 Participants	37 participants n=10 Participants	36 participants n=115 Participants	9 participants n=24 Participants	126 participants n=42 Participants
Region of Enrollment Australia	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	3 participants n=4 Participants	2 participants n=21 Participants	2 participants n=10 Participants	7 participants n=115 Participants	3 participants n=24 Participants	17 participants n=42 Participants
Region of Enrollment Canada	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	1 participants n=10 Participants	0 participants n=115 Participants	0 participants n=24 Participants	1 participants n=42 Participants
ECOG Performance Status ECOG 0	2 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants	5 Participants n=21 Participants	8 Participants n=10 Participants	13 Participants n=115 Participants	4 Participants n=24 Participants	39 Participants n=42 Participants
ECOG Performance Status ECOG 1	4 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	10 Participants n=4 Participants	16 Participants n=21 Participants	32 Participants n=10 Participants	29 Participants n=115 Participants	8 Participants n=24 Participants	103 Participants n=42 Participants
ECOG Performance Status Not reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants	0 Participants n=24 Participants	3 Participants n=42 Participants
Height	164.34 Centimeters STANDARD_DEVIATION 10.12 • n=5 Participants	168.5 Centimeters STANDARD_DEVIATION 6.44 • n=7 Participants	170.4 Centimeters STANDARD_DEVIATION 7.66 • n=5 Participants	173.0 Centimeters STANDARD_DEVIATION 10.41 • n=4 Participants	173.4 Centimeters STANDARD_DEVIATION 9.18 • n=21 Participants	169.4 Centimeters STANDARD_DEVIATION 9.62 • n=10 Participants	175.3 Centimeters STANDARD_DEVIATION 6.31 • n=115 Participants	167.0 Centimeters STANDARD_DEVIATION 15.93 • n=24 Participants	171.8 Centimeters STANDARD_DEVIATION 9.72 • n=42 Participants
Weight	73.2 Kilograms STANDARD_DEVIATION 8.67 • n=5 Participants	63.1 Kilograms STANDARD_DEVIATION 16.14 • n=7 Participants	79.0 Kilograms STANDARD_DEVIATION 4.55 • n=5 Participants	81.5 Kilograms STANDARD_DEVIATION 24.82 • n=4 Participants	82.7 Kilograms STANDARD_DEVIATION 17.63 • n=21 Participants	74.4 Kilograms STANDARD_DEVIATION 17.15 • n=10 Participants	75.6 Kilograms STANDARD_DEVIATION 13.60 • n=115 Participants	91.1 Kilograms STANDARD_DEVIATION 35.44 • n=24 Participants	78.0 Kilograms STANDARD_DEVIATION 19.43 • n=42 Participants
B7H3 immunohistochemistry status Positive	4 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	16 Participants n=4 Participants	15 Participants n=21 Participants	32 Participants n=10 Participants	37 Participants n=115 Participants	9 Participants n=24 Participants	116 Participants n=42 Participants
B7H3 immunohistochemistry status Negative	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	4 Participants n=21 Participants	3 Participants n=10 Participants	5 Participants n=115 Participants	3 Participants n=24 Participants	15 Participants n=42 Participants
B7H3 immunohistochemistry status Unknown	2 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants	5 Participants n=10 Participants	1 Participants n=115 Participants	0 Participants n=24 Participants	14 Participants n=42 Participants

PRIMARY outcome

Timeframe: Study Day 1-42, for Cohorts 1-4.

Population: Participants in Cohorts 1-4 are evaluable for DLT during the first 42 days of treatment.

Dose-limiting toxicities are severe side effects related to study treatment that may cause dose interruptions, dose reductions, or withdrawal of treatment.

Outcome measures

Outcome measures
Measure	Cohort 4 enoblituzumab 15 mg/kg IV and retifanlimab 375 mg IV every three weeks up to 17 doses.	Cohort 1 n=6 Participants enoblituzumab 3 mg/kg IV weekly for up to 51 doses plus pembrolizumab 2 mg/kg every 3 weeks for up to 17 doses	Cohort 2 n=3 Participants enoblituzumab 10 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg every 3 weeks for up to 17 doses	Cohort 3 n=3 Participants enoblituzumab 15 mg/kg IV weekly for up to 51 doses pembrolizumab 2 mg/kg every 3 weeks for up to 17 doses	Cohort 4 n=12 Participants enoblituzumab 15 mg/kg IV and retifanlimab 375 mg IV every three weeks for up to 17 doses.	Urothelial Cancer Cohort enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	NSCLC Cohort: PD1/PDL1 Naïve enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	NSCLC Cohort: PD1/PDL1 Experienced enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	SCCHN Cohort: PD1/PDL1 Naïve enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	SCCHN Cohort: PD1/PDL1 Experienced enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses
Number of Participants With Dose-limiting Toxicities (DLT) After Administration of Enoblituzumab and Pembrolizumab or Retifanlimab	—	1 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, 1, 4, 24, and 72 hours after the first dose.

Population: All participants who received at least one dose of study treatment, date and time of dose administration and relative PK sample collection are known and have sufficient concentration data to derive the PK parameter. PK parameters are analyzed by the dose received. Participants in Cohort 3 and the Expansion Cohorts were combined since all participants were dosed at 15 mg/kg.

The highest measured concentration of enoblizuzumab in the bloodstream.

Outcome measures

Outcome measures
Measure	Cohort 4 enoblituzumab 15 mg/kg IV and retifanlimab 375 mg IV every three weeks up to 17 doses.	Cohort 1 n=6 Participants enoblituzumab 3 mg/kg IV weekly for up to 51 doses plus pembrolizumab 2 mg/kg every 3 weeks for up to 17 doses	Cohort 2 n=3 Participants enoblituzumab 10 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg every 3 weeks for up to 17 doses	Cohort 3 n=122 Participants enoblituzumab 15 mg/kg IV weekly for up to 51 doses pembrolizumab 2 mg/kg every 3 weeks for up to 17 doses	Cohort 4 n=12 Participants enoblituzumab 15 mg/kg IV and retifanlimab 375 mg IV every three weeks for up to 17 doses.	Urothelial Cancer Cohort enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	NSCLC Cohort: PD1/PDL1 Naïve enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	NSCLC Cohort: PD1/PDL1 Experienced enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	SCCHN Cohort: PD1/PDL1 Naïve enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	SCCHN Cohort: PD1/PDL1 Experienced enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses
Mean Maximum Concentration of Enoblituzumab	—	223.5 mcg/mL Standard Deviation 62.80	860.0 mcg/mL Standard Deviation 434.1	995.4 mcg/mL Standard Deviation 294.4	580.2 mcg/mL Standard Deviation 133.1	—	—	—	—	—

SECONDARY outcome

Timeframe: At baseline, and Day 7.

Trough concentration is the concentration measured before the a subsequent dose of enoblituzumab. MGA271 is characterized by a biphasic concentration-time profile and PPK was used to estimate PK parameters at each dose level

Outcome measures

Outcome measures
Measure	Cohort 4 enoblituzumab 15 mg/kg IV and retifanlimab 375 mg IV every three weeks up to 17 doses.	Cohort 1 n=6 Participants enoblituzumab 3 mg/kg IV weekly for up to 51 doses plus pembrolizumab 2 mg/kg every 3 weeks for up to 17 doses	Cohort 2 n=3 Participants enoblituzumab 10 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg every 3 weeks for up to 17 doses	Cohort 3 n=122 Participants enoblituzumab 15 mg/kg IV weekly for up to 51 doses pembrolizumab 2 mg/kg every 3 weeks for up to 17 doses	Cohort 4 n=12 Participants enoblituzumab 15 mg/kg IV and retifanlimab 375 mg IV every three weeks for up to 17 doses.	Urothelial Cancer Cohort enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	NSCLC Cohort: PD1/PDL1 Naïve enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	NSCLC Cohort: PD1/PDL1 Experienced enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	SCCHN Cohort: PD1/PDL1 Naïve enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	SCCHN Cohort: PD1/PDL1 Experienced enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses
Mean Trough Concentration of Enoblituzumab	—	146.2 mcg/mL Standard Deviation 48.1	551.0 mcg/mL Standard Deviation 323.7	607.3 mcg/mL Standard Deviation 246.4	180.2 mcg/mL Standard Deviation 88.0	—	—	—	—	—

SECONDARY outcome

Timeframe: At baseline, 1, 4, 24, 72 hours, and Day 7.

AUC is the total body exposure to enoblituzumab MGA271 is characterized by a biphasic concentration-time profile and PPK was used to estimate PK parameters at each dose level

Outcome measures

Outcome measures
Measure	Cohort 4 enoblituzumab 15 mg/kg IV and retifanlimab 375 mg IV every three weeks up to 17 doses.	Cohort 1 n=6 Participants enoblituzumab 3 mg/kg IV weekly for up to 51 doses plus pembrolizumab 2 mg/kg every 3 weeks for up to 17 doses	Cohort 2 n=3 Participants enoblituzumab 10 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg every 3 weeks for up to 17 doses	Cohort 3 n=122 Participants enoblituzumab 15 mg/kg IV weekly for up to 51 doses pembrolizumab 2 mg/kg every 3 weeks for up to 17 doses	Cohort 4 n=12 Participants enoblituzumab 15 mg/kg IV and retifanlimab 375 mg IV every three weeks for up to 17 doses.	Urothelial Cancer Cohort enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	NSCLC Cohort: PD1/PDL1 Naïve enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	NSCLC Cohort: PD1/PDL1 Experienced enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	SCCHN Cohort: PD1/PDL1 Naïve enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	SCCHN Cohort: PD1/PDL1 Experienced enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses
Mean Area Under the Concentration Time Curve (AUC) From Time 0 to Day 7 of Enoblituzumab	—	1207 mcg/mL*day Standard Deviation 363.3	4540 mcg/mL*day Standard Deviation 2445	5175 mcg/mL*day Standard Deviation 1820	5919 mcg/mL*day Standard Deviation 2009	—	—	—	—	—

SECONDARY outcome

Timeframe: At baseline, 1, 4, 24, 72 hours, and Day 7.

Drug clearance is the amount of drug removed from the bloodstream by the body per unit of time.

Outcome measures

Outcome measures
Measure	Cohort 4 enoblituzumab 15 mg/kg IV and retifanlimab 375 mg IV every three weeks up to 17 doses.	Cohort 1 n=6 Participants enoblituzumab 3 mg/kg IV weekly for up to 51 doses plus pembrolizumab 2 mg/kg every 3 weeks for up to 17 doses	Cohort 2 n=3 Participants enoblituzumab 10 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg every 3 weeks for up to 17 doses	Cohort 3 n=122 Participants enoblituzumab 15 mg/kg IV weekly for up to 51 doses pembrolizumab 2 mg/kg every 3 weeks for up to 17 doses	Cohort 4 n=12 Participants enoblituzumab 15 mg/kg IV and retifanlimab 375 mg IV every three weeks for up to 17 doses.	Urothelial Cancer Cohort enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	NSCLC Cohort: PD1/PDL1 Naïve enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	NSCLC Cohort: PD1/PDL1 Experienced enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	SCCHN Cohort: PD1/PDL1 Naïve enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	SCCHN Cohort: PD1/PDL1 Experienced enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses
Mean Clearance of Enoblituzumab	—	0.155 liters per day Standard Deviation 0.032	0.154 liters per day Standard Deviation 0.076	0.235 liters per day Standard Deviation 0.079	0.210 liters per day Standard Deviation 0.108	—	—	—	—	—

SECONDARY outcome

Timeframe: At baseline, 1, 4, 24, and 72 and Day 7.

The volume of distribution is related to how much drug is distributed to body tissues, or remains in the bloodstream

Outcome measures

Outcome measures
Measure	Cohort 4 enoblituzumab 15 mg/kg IV and retifanlimab 375 mg IV every three weeks up to 17 doses.	Cohort 1 n=6 Participants enoblituzumab 3 mg/kg IV weekly for up to 51 doses plus pembrolizumab 2 mg/kg every 3 weeks for up to 17 doses	Cohort 2 n=3 Participants enoblituzumab 10 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg every 3 weeks for up to 17 doses	Cohort 3 n=122 Participants enoblituzumab 15 mg/kg IV weekly for up to 51 doses pembrolizumab 2 mg/kg every 3 weeks for up to 17 doses	Cohort 4 n=12 Participants enoblituzumab 15 mg/kg IV and retifanlimab 375 mg IV every three weeks for up to 17 doses.	Urothelial Cancer Cohort enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	NSCLC Cohort: PD1/PDL1 Naïve enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	NSCLC Cohort: PD1/PDL1 Experienced enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	SCCHN Cohort: PD1/PDL1 Naïve enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	SCCHN Cohort: PD1/PDL1 Experienced enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses
Mean Volume of Distribution at Steady State of Enoblituzumab in Combination With Pembrolizumab or Retifanlimab	—	6.053 liters Standard Deviation 0.986	4.340 liters Standard Deviation 0.466	5.814 liters Standard Deviation 1.357	6.299 liters Standard Deviation 1.009	—	—	—	—	—

SECONDARY outcome

Timeframe: At baseline, 1, 4, 24, and 72 and Day 7.

Terminal half-life is the time required to divide the plasma concentration by two after reaching pseudo-equilibrium MGA271 is characterized by a biphasic concentration-time profile and PPK was used to estimate PK parameters at each dose level

Outcome measures

Outcome measures
Measure	Cohort 4 enoblituzumab 15 mg/kg IV and retifanlimab 375 mg IV every three weeks up to 17 doses.	Cohort 1 n=6 Participants enoblituzumab 3 mg/kg IV weekly for up to 51 doses plus pembrolizumab 2 mg/kg every 3 weeks for up to 17 doses	Cohort 2 n=3 Participants enoblituzumab 10 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg every 3 weeks for up to 17 doses	Cohort 3 n=122 Participants enoblituzumab 15 mg/kg IV weekly for up to 51 doses pembrolizumab 2 mg/kg every 3 weeks for up to 17 doses	Cohort 4 n=12 Participants enoblituzumab 15 mg/kg IV and retifanlimab 375 mg IV every three weeks for up to 17 doses.	Urothelial Cancer Cohort enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	NSCLC Cohort: PD1/PDL1 Naïve enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	NSCLC Cohort: PD1/PDL1 Experienced enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	SCCHN Cohort: PD1/PDL1 Naïve enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	SCCHN Cohort: PD1/PDL1 Experienced enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses
Mean Terminal Half-life of Enoblituzumab in Combination With Pembrolizumab or Retifanlimab	—	29.22 days Standard Deviation 4.337	23.27 days Standard Deviation 8.001	20.05 days Standard Deviation 6.975	26.63 days Standard Deviation 11.43	—	—	—	—	—

SECONDARY outcome

Timeframe: Every 3 weeks throughout the study, average duration 13 months.

Population: All participants who received at least one dose of enoblituzumab and have at least one ADA sample sufficient for analysis. ADA samples are analyzed by the dose received. Participants in Cohort 3 and the Expansion Cohorts were combined since all participants were dosed at 15 mg/kg.

Outcome measures

Outcome measures
Measure	Cohort 4 enoblituzumab 15 mg/kg IV and retifanlimab 375 mg IV every three weeks up to 17 doses.	Cohort 1 n=6 Participants enoblituzumab 3 mg/kg IV weekly for up to 51 doses plus pembrolizumab 2 mg/kg every 3 weeks for up to 17 doses	Cohort 2 n=3 Participants enoblituzumab 10 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg every 3 weeks for up to 17 doses	Cohort 3 n=124 Participants enoblituzumab 15 mg/kg IV weekly for up to 51 doses pembrolizumab 2 mg/kg every 3 weeks for up to 17 doses	Cohort 4 n=12 Participants enoblituzumab 15 mg/kg IV and retifanlimab 375 mg IV every three weeks for up to 17 doses.	Urothelial Cancer Cohort enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	NSCLC Cohort: PD1/PDL1 Naïve enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	NSCLC Cohort: PD1/PDL1 Experienced enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	SCCHN Cohort: PD1/PDL1 Naïve enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	SCCHN Cohort: PD1/PDL1 Experienced enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses
Number of Participants That Develop Enoblituzumab Anti-drug Antibodies (ADA) Negative at baseline and negative post-baseline	—	3 Participants	3 Participants	99 Participants	10 Participants	—	—	—	—	—
Number of Participants That Develop Enoblituzumab Anti-drug Antibodies (ADA) Negative at baseline and positive at least once post-baseline	—	1 Participants	0 Participants	1 Participants	1 Participants	—	—	—	—	—
Number of Participants That Develop Enoblituzumab Anti-drug Antibodies (ADA) Negative at baseline and not done post-baseline	—	0 Participants	0 Participants	7 Participants	0 Participants	—	—	—	—	—
Number of Participants That Develop Enoblituzumab Anti-drug Antibodies (ADA) Positive at baseline and negative post-baseline	—	0 Participants	0 Participants	7 Participants	0 Participants	—	—	—	—	—
Number of Participants That Develop Enoblituzumab Anti-drug Antibodies (ADA) Positive at baseline and positive at least once post-baseline	—	1 Participants	0 Participants	2 Participants	0 Participants	—	—	—	—	—
Number of Participants That Develop Enoblituzumab Anti-drug Antibodies (ADA) Positive at baseline and not done post-baseline	—	0 Participants	0 Participants	4 Participants	0 Participants	—	—	—	—	—
Number of Participants That Develop Enoblituzumab Anti-drug Antibodies (ADA) Not done at baseline and not done post-baseline	—	0 Participants	0 Participants	2 Participants	0 Participants	—	—	—	—	—
Number of Participants That Develop Enoblituzumab Anti-drug Antibodies (ADA) Not done at baseline and negative post-baseline	—	1 Participants	0 Participants	2 Participants	1 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Every 3 weeks throughout the study, average duration 13 months.

Population: All participants who received at least one dose of retifanlimab and have at least one ADA sample sufficient for analysis.

Outcome measures

Outcome measures
Measure	Cohort 4 enoblituzumab 15 mg/kg IV and retifanlimab 375 mg IV every three weeks up to 17 doses.	Cohort 1 n=11 Participants enoblituzumab 3 mg/kg IV weekly for up to 51 doses plus pembrolizumab 2 mg/kg every 3 weeks for up to 17 doses	Cohort 2 enoblituzumab 10 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg every 3 weeks for up to 17 doses	Cohort 3 enoblituzumab 15 mg/kg IV weekly for up to 51 doses pembrolizumab 2 mg/kg every 3 weeks for up to 17 doses	Cohort 4 enoblituzumab 15 mg/kg IV and retifanlimab 375 mg IV every three weeks for up to 17 doses.	Urothelial Cancer Cohort enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	NSCLC Cohort: PD1/PDL1 Naïve enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	NSCLC Cohort: PD1/PDL1 Experienced enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	SCCHN Cohort: PD1/PDL1 Naïve enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	SCCHN Cohort: PD1/PDL1 Experienced enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses
Number of Participants That Develop Retifanlimab ADA Negative at baseline and negative post-baseline	—	11 Participants	—	—	—	—	—	—	—	—
Number of Participants That Develop Retifanlimab ADA Negative at baseline and positive at least once post-baseline	—	0 Participants	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Six weeks after the first dose, then every 9 weeks throughout study until discontinuation, average 13 months

Population: Analysis performed using Response Evaluable Population that includes participants with baseline tumor assessment and at least 1 post-baseline tumor assessment.. NSCLC and SCCHN cohorts were subdivided by prior exposure to a PD1 or PDL1 inhibitor for the evaluation of efficacy. .

The number of participants with a complete response (CR) or partial response (PR) to enoblituzumab in combination with pembrolizumab or retifanlimab RECIST 1.1 criteria.

Outcome measures

Outcome measures
Measure	Cohort 4 n=12 Participants enoblituzumab 15 mg/kg IV and retifanlimab 375 mg IV every three weeks up to 17 doses.	Cohort 1 n=6 Participants enoblituzumab 3 mg/kg IV weekly for up to 51 doses plus pembrolizumab 2 mg/kg every 3 weeks for up to 17 doses	Cohort 2 n=3 Participants enoblituzumab 10 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg every 3 weeks for up to 17 doses	Cohort 3 n=3 Participants enoblituzumab 15 mg/kg IV weekly for up to 51 doses pembrolizumab 2 mg/kg every 3 weeks for up to 17 doses	Cohort 4 n=15 Participants enoblituzumab 15 mg/kg IV and retifanlimab 375 mg IV every three weeks for up to 17 doses.	Urothelial Cancer Cohort n=17 Participants enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	NSCLC Cohort: PD1/PDL1 Naïve n=15 Participants enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	NSCLC Cohort: PD1/PDL1 Experienced n=19 Participants enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	SCCHN Cohort: PD1/PDL1 Naïve n=16 Participants enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	SCCHN Cohort: PD1/PDL1 Experienced n=19 Participants enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses
Objective Response Rate	16.7 percentage of participants Interval 2.1 to 48.4	0 percentage of participants Interval 0.0 to 45.9	33.3 percentage of participants Interval 0.8 to 90.6	0 percentage of participants Interval 0.0 to 70.8	6.7 percentage of participants Interval 0.2 to 31.9	5.9 percentage of participants Interval 0.1 to 28.7	33.3 percentage of participants Interval 11.8 to 61.6	10.5 percentage of participants Interval 1.3 to 33.1	31.3 percentage of participants Interval 11.0 to 58.7	0 percentage of participants Interval 0.0 to 17.6

SECONDARY outcome

Timeframe: Six weeks after the first dose, then every 9 weeks throughout study until discontinuation, average 13 months

The number of participants with a complete response (CR) or partial response (PR) to enoblituzumab in combination with pembrolizumab or retifanlimab using irRECIST 1.1 criteria.

Outcome measures

Outcome measures
Measure	Cohort 4 n=12 Participants enoblituzumab 15 mg/kg IV and retifanlimab 375 mg IV every three weeks up to 17 doses.	Cohort 1 n=6 Participants enoblituzumab 3 mg/kg IV weekly for up to 51 doses plus pembrolizumab 2 mg/kg every 3 weeks for up to 17 doses	Cohort 2 n=3 Participants enoblituzumab 10 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg every 3 weeks for up to 17 doses	Cohort 3 n=3 Participants enoblituzumab 15 mg/kg IV weekly for up to 51 doses pembrolizumab 2 mg/kg every 3 weeks for up to 17 doses	Cohort 4 n=15 Participants enoblituzumab 15 mg/kg IV and retifanlimab 375 mg IV every three weeks for up to 17 doses.	Urothelial Cancer Cohort n=17 Participants enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	NSCLC Cohort: PD1/PDL1 Naïve n=15 Participants enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	NSCLC Cohort: PD1/PDL1 Experienced n=19 Participants enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	SCCHN Cohort: PD1/PDL1 Naïve n=16 Participants enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	SCCHN Cohort: PD1/PDL1 Experienced n=19 Participants enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses
ORR Using Immune-related (ir) RECIST Criteria	25.0 percentage of participants Interval 5.5 to 57.2	0 percentage of participants Interval 0.0 to 45.9	33.3 percentage of participants Interval 0.8 to 90.6	0 percentage of participants Interval 0.0 to 70.8	6.7 percentage of participants Interval 0.2 to 31.9	5.9 percentage of participants Interval 0.1 to 28.7	33.3 percentage of participants Interval 11.8 to 61.6	5.3 percentage of participants Interval 0.1 to 26.0	31.3 percentage of participants Interval 11.0 to 58.7	0 percentage of participants Interval 0.0 to 17.6

SECONDARY outcome

Timeframe: Evaluated at 6 weeks then every 9 weeks throughout the study until discontinuation, average 13 months.

The participants best response to treatment during their study participation. Responses are categorized as CR, PR, stable disease (SD), progressive disease (PD) or not evaluated (NE)

Outcome measures

Outcome measures
Measure	Cohort 4 n=12 Participants enoblituzumab 15 mg/kg IV and retifanlimab 375 mg IV every three weeks up to 17 doses.	Cohort 1 n=6 Participants enoblituzumab 3 mg/kg IV weekly for up to 51 doses plus pembrolizumab 2 mg/kg every 3 weeks for up to 17 doses	Cohort 2 n=3 Participants enoblituzumab 10 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg every 3 weeks for up to 17 doses	Cohort 3 n=3 Participants enoblituzumab 15 mg/kg IV weekly for up to 51 doses pembrolizumab 2 mg/kg every 3 weeks for up to 17 doses	Cohort 4 n=15 Participants enoblituzumab 15 mg/kg IV and retifanlimab 375 mg IV every three weeks for up to 17 doses.	Urothelial Cancer Cohort n=17 Participants enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	NSCLC Cohort: PD1/PDL1 Naïve n=15 Participants enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	NSCLC Cohort: PD1/PDL1 Experienced n=19 Participants enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	SCCHN Cohort: PD1/PDL1 Naïve n=16 Participants enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	SCCHN Cohort: PD1/PDL1 Experienced n=19 Participants enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses
Best Overall Response (RECIST 1.1) CR	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Best Overall Response (RECIST 1.1) PR	2 Participants	0 Participants	1 Participants	0 Participants	1 Participants	1 Participants	5 Participants	2 Participants	4 Participants	0 Participants
Best Overall Response (RECIST 1.1) SD	7 Participants	4 Participants	0 Participants	3 Participants	5 Participants	8 Participants	9 Participants	9 Participants	4 Participants	9 Participants
Best Overall Response (RECIST 1.1) PD	3 Participants	1 Participants	2 Participants	0 Participants	9 Participants	8 Participants	1 Participants	8 Participants	7 Participants	10 Participants
Best Overall Response (RECIST 1.1) NE	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Evaluated at 6 weeks then every 9 weeks throughout the study until discontinuation, average 13 months.

The participants best response to treatment during their study participation. Responses are categorized as CR, PR, stable disease (SD), progressive disease (PD) or not evaluated (NE)

Outcome measures

Outcome measures
Measure	Cohort 4 n=12 Participants enoblituzumab 15 mg/kg IV and retifanlimab 375 mg IV every three weeks up to 17 doses.	Cohort 1 n=6 Participants enoblituzumab 3 mg/kg IV weekly for up to 51 doses plus pembrolizumab 2 mg/kg every 3 weeks for up to 17 doses	Cohort 2 n=3 Participants enoblituzumab 10 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg every 3 weeks for up to 17 doses	Cohort 3 n=3 Participants enoblituzumab 15 mg/kg IV weekly for up to 51 doses pembrolizumab 2 mg/kg every 3 weeks for up to 17 doses	Cohort 4 n=15 Participants enoblituzumab 15 mg/kg IV and retifanlimab 375 mg IV every three weeks for up to 17 doses.	Urothelial Cancer Cohort n=17 Participants enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	NSCLC Cohort: PD1/PDL1 Naïve n=15 Participants enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	NSCLC Cohort: PD1/PDL1 Experienced n=19 Participants enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	SCCHN Cohort: PD1/PDL1 Naïve n=16 Participants enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	SCCHN Cohort: PD1/PDL1 Experienced n=19 Participants enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses
Best Overall Response (irRECIST 1.1) CR	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Best Overall Response (irRECIST 1.1) PR	3 Participants	0 Participants	1 Participants	0 Participants	1 Participants	1 Participants	5 Participants	1 Participants	4 Participants	0 Participants
Best Overall Response (irRECIST 1.1) SD	6 Participants	4 Participants	0 Participants	3 Participants	7 Participants	8 Participants	10 Participants	11 Participants	5 Participants	10 Participants
Best Overall Response (irRECIST 1.1) PD	3 Participants	1 Participants	2 Participants	0 Participants	7 Participants	8 Participants	0 Participants	7 Participants	6 Participants	9 Participants
Best Overall Response (irRECIST 1.1) NE	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Evaluated at 6 weeks then every 9 weeks throughout the study until discontinuation, average13 months.

The duration of response displays the minimum and maximum range in months from the first documented CR or PR until disease progression or death, whichever is first.

Outcome measures

Outcome measures
Measure	Cohort 4 n=12 Participants enoblituzumab 15 mg/kg IV and retifanlimab 375 mg IV every three weeks up to 17 doses.	Cohort 1 n=6 Participants enoblituzumab 3 mg/kg IV weekly for up to 51 doses plus pembrolizumab 2 mg/kg every 3 weeks for up to 17 doses	Cohort 2 n=3 Participants enoblituzumab 10 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg every 3 weeks for up to 17 doses	Cohort 3 n=3 Participants enoblituzumab 15 mg/kg IV weekly for up to 51 doses pembrolizumab 2 mg/kg every 3 weeks for up to 17 doses	Cohort 4 n=15 Participants enoblituzumab 15 mg/kg IV and retifanlimab 375 mg IV every three weeks for up to 17 doses.	Urothelial Cancer Cohort n=17 Participants enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	NSCLC Cohort: PD1/PDL1 Naïve n=15 Participants enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	NSCLC Cohort: PD1/PDL1 Experienced n=19 Participants enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	SCCHN Cohort: PD1/PDL1 Naïve n=16 Participants enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	SCCHN Cohort: PD1/PDL1 Experienced n=19 Participants enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses
Minimum and Maximum Duration of Response (DoR) Per irRECIST 1.1 Minimum DoR	3.45 months	NA months There were no responses in this group.	25.95 months	NA months There were no responses in this group.	6.14 months	28.89 months	3.48 months	4.44 months	4.17 months	NA months There were no responses in this group
Minimum and Maximum Duration of Response (DoR) Per irRECIST 1.1 Maximum DoR	6.24 months	NA months There were no responses in this group.	25.95 months	NA months There were no responses in this group.	6.14 months	25.89 months	32.00 months	4.44 months	23.72 months	NA months There were no responses in this group

SECONDARY outcome

Timeframe: Evaluated at 6 weeks then every 9 weeks throughout the study until discontinuation, average 13 months.

The duration of response displays the minimum and maximum range in months from the first documented CR or PR until disease progression or death, whichever is first.

Outcome measures

Outcome measures
Measure	Cohort 4 n=12 Participants enoblituzumab 15 mg/kg IV and retifanlimab 375 mg IV every three weeks up to 17 doses.	Cohort 1 n=6 Participants enoblituzumab 3 mg/kg IV weekly for up to 51 doses plus pembrolizumab 2 mg/kg every 3 weeks for up to 17 doses	Cohort 2 n=3 Participants enoblituzumab 10 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg every 3 weeks for up to 17 doses	Cohort 3 n=3 Participants enoblituzumab 15 mg/kg IV weekly for up to 51 doses pembrolizumab 2 mg/kg every 3 weeks for up to 17 doses	Cohort 4 n=15 Participants enoblituzumab 15 mg/kg IV and retifanlimab 375 mg IV every three weeks for up to 17 doses.	Urothelial Cancer Cohort n=17 Participants enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	NSCLC Cohort: PD1/PDL1 Naïve n=15 Participants enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	NSCLC Cohort: PD1/PDL1 Experienced n=19 Participants enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	SCCHN Cohort: PD1/PDL1 Naïve n=16 Participants enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	SCCHN Cohort: PD1/PDL1 Experienced n=19 Participants enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses
Minimum and Maximum DoR Per RECIST 1.1 Minimum DoR	3.45 months	NA months There were no responses in this group	25.95 months	NA months There were no responses in this group	6.14 months	25.89 months	3.48 months	4.44 months	4.17 months	NA months There were no responses in this group
Minimum and Maximum DoR Per RECIST 1.1 Maximum DoR	6.24 months	NA months There were no responses in this group	25.95 months	NA months There were no responses in this group	6.14 months	25.89 months	32.00 months	4.44 months	23.72 months	NA months There were no responses in this group

SECONDARY outcome

Timeframe: Evaluated at 6 weeks then every 9 weeks throughout the study until discontinuation, average 13 months.

Population: PFS was calculated using the safety population. NSCLC and SCCHN cohorts were subdivided by prior exposure to a PD1 or PDL1 inhibitor for the evaluation of efficacy only. Safety assessment was conducted regardless of prior exposure to a PD1 or PDL1 inhibitor.

The time from the first infusion of pembrolizumab or retifanlimab until documented disease progression or death from any cause.

Outcome measures

Outcome measures
Measure	Cohort 4 n=12 Participants enoblituzumab 15 mg/kg IV and retifanlimab 375 mg IV every three weeks up to 17 doses.	Cohort 1 n=6 Participants enoblituzumab 3 mg/kg IV weekly for up to 51 doses plus pembrolizumab 2 mg/kg every 3 weeks for up to 17 doses	Cohort 2 n=3 Participants enoblituzumab 10 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg every 3 weeks for up to 17 doses	Cohort 3 n=3 Participants enoblituzumab 15 mg/kg IV weekly for up to 51 doses pembrolizumab 2 mg/kg every 3 weeks for up to 17 doses	Cohort 4 n=17 Participants enoblituzumab 15 mg/kg IV and retifanlimab 375 mg IV every three weeks for up to 17 doses.	Urothelial Cancer Cohort n=21 Participants enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	NSCLC Cohort: PD1/PDL1 Naïve n=17 Participants enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	NSCLC Cohort: PD1/PDL1 Experienced n=23 Participants enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	SCCHN Cohort: PD1/PDL1 Naïve n=19 Participants enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	SCCHN Cohort: PD1/PDL1 Experienced n=24 Participants enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses
Median Progression-free Survival (PFS) Using RECIST 1.1	4.8 months Interval 1.38 to 11.96	NA months Interval 1.41 to The upper limit of the confidence level was not reached.	1.4 months Interval 1.22 to The upper limit of the confidence level was not reached.	3.6 months Interval 3.32 to 3.91	2.0 months Interval 1.38 to 4.83	2.2 months Interval 1.28 to 5.52	5.1 months Interval 3.19 to The upper limit of the confidence level was not reached.	3.5 months Interval 1.41 to 5.75	3.5 months Interval 1.28 to 13.83	1.4 months Interval 1.35 to 3.55

SECONDARY outcome

Timeframe: Evaluated at 6 weeks then every 9 weeks throughout the study until discontinuation, average 13 months.

The time from the first infusion of pembrolizumab or retifanlimab until documented disease progression or death from any cause.

Outcome measures

Outcome measures
Measure	Cohort 4 n=12 Participants enoblituzumab 15 mg/kg IV and retifanlimab 375 mg IV every three weeks up to 17 doses.	Cohort 1 n=6 Participants enoblituzumab 3 mg/kg IV weekly for up to 51 doses plus pembrolizumab 2 mg/kg every 3 weeks for up to 17 doses	Cohort 2 n=3 Participants enoblituzumab 10 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg every 3 weeks for up to 17 doses	Cohort 3 n=3 Participants enoblituzumab 15 mg/kg IV weekly for up to 51 doses pembrolizumab 2 mg/kg every 3 weeks for up to 17 doses	Cohort 4 n=17 Participants enoblituzumab 15 mg/kg IV and retifanlimab 375 mg IV every three weeks for up to 17 doses.	Urothelial Cancer Cohort n=21 Participants enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	NSCLC Cohort: PD1/PDL1 Naïve n=17 Participants enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	NSCLC Cohort: PD1/PDL1 Experienced n=23 Participants enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	SCCHN Cohort: PD1/PDL1 Naïve n=19 Participants enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	SCCHN Cohort: PD1/PDL1 Experienced n=24 Participants enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses
Median PFS Using irRECIST 1.1 Criteria	4.8 months Interval 1.38 to 11.96	NA months Interval 1.41 to The upper limit of the confidence level was not reached.	1.4 months Interval 1.22 to The upper limit of the confidence level was not reached.	3.6 months Interval 3.32 to 3.91	2.0 months Interval 1.38 to 4.83	2.2 months Interval 1.28 to 5.52	5.1 months Interval 3.19 to The upper limit of the confidence level was not reached.	3.5 months Interval 1.45 to 5.75	3.5 months Interval 1.28 to 13.83	1.4 months Interval 1.35 to 3.55

SECONDARY outcome

Timeframe: Evaluated at 6 weeks then every 9 weeks throughout the study until discontinuation, average 13 months.

Population: OS was calculated using the safety population. NSCLC and SCCHN cohorts were subdivided by prior exposure to a PD1 or PDL1 inhibitor for the evaluation of efficacy only. Safety assessment was conducted regardless of prior exposure to a PD1 or PDL1 inhibitor.

The time from the first infusion of pembrolizumab or retifanlimab until death from any cause.

Outcome measures

Outcome measures
Measure	Cohort 4 n=12 Participants enoblituzumab 15 mg/kg IV and retifanlimab 375 mg IV every three weeks up to 17 doses.	Cohort 1 n=6 Participants enoblituzumab 3 mg/kg IV weekly for up to 51 doses plus pembrolizumab 2 mg/kg every 3 weeks for up to 17 doses	Cohort 2 n=3 Participants enoblituzumab 10 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg every 3 weeks for up to 17 doses	Cohort 3 n=3 Participants enoblituzumab 15 mg/kg IV weekly for up to 51 doses pembrolizumab 2 mg/kg every 3 weeks for up to 17 doses	Cohort 4 n=17 Participants enoblituzumab 15 mg/kg IV and retifanlimab 375 mg IV every three weeks for up to 17 doses.	Urothelial Cancer Cohort n=21 Participants enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	NSCLC Cohort: PD1/PDL1 Naïve n=17 Participants enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	NSCLC Cohort: PD1/PDL1 Experienced n=23 Participants enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	SCCHN Cohort: PD1/PDL1 Naïve n=19 Participants enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses	SCCHN Cohort: PD1/PDL1 Experienced n=24 Participants enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses
Median Overall Survival	NA months There were no death events in this cohort by the end of the study. OS and confidence interval could not be calculated.	18.0 months Interval 7.1 to The upper limit of the confidence interval was not reached.	10.3 months Interval 7.75 to The upper limit of the confidence interval was not reached.	6.3 months Interval 5.82 to 6.7	14.4 months Interval 9.0 to The upper limit of the confidence interval was not reached.	5.7 months Interval 3.09 to 11.1	10.3 months Interval 6.28 to 18.5	6.0 months Interval 2.96 to 10.78	17.9 months Interval 5.13 to The upper limit of the confidence interval was not reached.	6.9 months Interval 4.75 to 9.69

Adverse Events

Cohort 1

Serious events: 1 serious events

Other events: 6 other events

Deaths: 4 deaths

Cohort 2

Serious events: 1 serious events

Other events: 3 other events

Deaths: 2 deaths

Cohort 3

Serious events: 2 serious events

Other events: 3 other events

Deaths: 2 deaths

Melanoma Cohort

Serious events: 8 serious events

Other events: 17 other events

Deaths: 11 deaths

Urothelial Cancer Cohort

Serious events: 4 serious events

Other events: 21 other events

Deaths: 16 deaths

NSCLC Cohort

Serious events: 14 serious events

Other events: 40 other events

Deaths: 33 deaths

SCCHN Cohort

Serious events: 18 serious events

Other events: 42 other events

Deaths: 30 deaths

Cohort 4

Serious events: 3 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cohort 1 n=6 participants at risk enoblituzumab 3 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses.	Cohort 2 n=3 participants at risk enoblituzumab 10 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses.	Cohort 3 n=3 participants at risk enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses.	Melanoma Cohort n=17 participants at risk enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses.	Urothelial Cancer Cohort n=21 participants at risk enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses.	NSCLC Cohort n=40 participants at risk enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses.	SCCHN Cohort n=43 participants at risk enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses.	Cohort 4 n=12 participants at risk enoblituzumab 15 mg/kg IV and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses.
Blood and lymphatic system disorders Granulomatous lymphadenitis	0.00% 0/6 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/17 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/21 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/40 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/43 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	8.3% 1/12 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.
Cardiac disorders Atrial fibrillation	0.00% 0/6 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	33.3% 1/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/17 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/21 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/40 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	4.7% 2/43 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/12 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.
Cardiac disorders Myocarditis	0.00% 0/6 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/17 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/21 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	2.5% 1/40 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	2.3% 1/43 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/12 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.
Cardiac disorders Atrioventricular block	0.00% 0/6 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/17 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/21 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/40 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	2.3% 1/43 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/12 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.
Cardiac disorders Cardiac arrest	0.00% 0/6 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/17 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/21 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/40 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	2.3% 1/43 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/12 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.
Cardiac disorders Myocardial infarction	0.00% 0/6 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	5.9% 1/17 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/21 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/40 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/43 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/12 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.
Cardiac disorders Pericardial effusion	0.00% 0/6 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/17 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/21 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	2.5% 1/40 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/43 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/12 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.
Endocrine disorders Adrenal insufficiency	0.00% 0/6 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	33.3% 1/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/17 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/21 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/40 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/43 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/12 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/6 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/17 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	4.8% 1/21 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/40 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/43 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/12 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.
Gastrointestinal disorders Colitis	0.00% 0/6 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/17 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/21 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	2.5% 1/40 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/43 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/12 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.
Gastrointestinal disorders Gastritis	0.00% 0/6 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/17 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/21 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/40 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	2.3% 1/43 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/12 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.
Gastrointestinal disorders Intestinal ischaemia	0.00% 0/6 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/17 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/21 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	2.5% 1/40 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/43 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/12 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.
Gastrointestinal disorders Intestinal perforation	0.00% 0/6 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/17 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/21 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	2.5% 1/40 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/43 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/12 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.
Gastrointestinal disorders Intussusception	0.00% 0/6 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	5.9% 1/17 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/21 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/40 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/43 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/12 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.
Gastrointestinal disorders Large intestinal obstruction	0.00% 0/6 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/17 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	4.8% 1/21 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/40 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/43 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/12 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/6 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	5.9% 1/17 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/21 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/40 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/43 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/12 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.
General disorders Non-cardiac chest pain	0.00% 0/6 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/17 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/21 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	2.5% 1/40 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/43 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/12 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.
General disorders Pain	0.00% 0/6 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	5.9% 1/17 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/21 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/40 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/43 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/12 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.
General disorders Pyrexia	0.00% 0/6 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	33.3% 1/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/17 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/21 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/40 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/43 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/12 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.
Immune system disorders Cytokine release syndrome	16.7% 1/6 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/17 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/21 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/40 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/43 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/12 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.
Infections and infestations Pneumonia	0.00% 0/6 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	5.9% 1/17 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/21 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/40 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	2.3% 1/43 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/12 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.
Infections and infestations Septic shock	0.00% 0/6 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/17 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/21 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	2.5% 1/40 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/43 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	8.3% 1/12 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.
Infections and infestations Staphylococcal bacteraemia	0.00% 0/6 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	11.8% 2/17 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/21 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/40 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/43 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/12 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.
Infections and infestations Bronchitis	0.00% 0/6 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/17 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/21 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	2.5% 1/40 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/43 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/12 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.
Infections and infestations Empyema	0.00% 0/6 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/17 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/21 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/40 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/43 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	8.3% 1/12 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.
Infections and infestations Mastoiditis	0.00% 0/6 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/17 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/21 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/40 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	2.3% 1/43 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/12 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.
Infections and infestations Sepsis	0.00% 0/6 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/17 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/21 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/40 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/43 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	8.3% 1/12 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.
Infections and infestations Sepsis syndrome	0.00% 0/6 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	5.9% 1/17 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/21 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/40 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/43 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/12 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/6 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	11.8% 2/17 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/21 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	5.0% 2/40 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	14.0% 6/43 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	8.3% 1/12 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.
Injury, poisoning and procedural complications Fall	0.00% 0/6 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/17 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/21 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	2.5% 1/40 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/43 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/12 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/6 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/17 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/21 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/40 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	2.3% 1/43 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/12 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.
Investigations Aspartate aminotransferase increased	0.00% 0/6 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/17 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/21 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/40 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	2.3% 1/43 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	8.3% 1/12 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.
Investigations Alanine aminotransferase increased	0.00% 0/6 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/17 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/21 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/40 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/43 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	8.3% 1/12 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/6 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/17 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	4.8% 1/21 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/40 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/43 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/12 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/6 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/17 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/21 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/40 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	2.3% 1/43 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/12 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/6 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/17 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/21 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	2.5% 1/40 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/43 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/12 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/6 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	5.9% 1/17 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/21 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/40 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/43 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/12 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/6 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/17 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/21 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/40 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	2.3% 1/43 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/12 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/6 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/17 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/21 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	2.5% 1/40 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/43 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/12 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.
Musculoskeletal and connective tissue disorders Pathological fracture	0.00% 0/6 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/17 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	4.8% 1/21 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/40 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/43 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/12 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour haemorrhage	0.00% 0/6 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/17 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/21 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	2.5% 1/40 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	2.3% 1/43 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	8.3% 1/12 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/6 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/17 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/21 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/40 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	2.3% 1/43 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/12 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/6 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/17 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/21 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/40 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/43 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	8.3% 1/12 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.
Nervous system disorders Cerebral artery thrombosis	0.00% 0/6 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/17 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	4.8% 1/21 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/40 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/43 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/12 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.
Nervous system disorders Dizziness	0.00% 0/6 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	33.3% 1/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/17 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/21 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/40 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/43 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/12 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.
Nervous system disorders Syncope	0.00% 0/6 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/17 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/21 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/40 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	2.3% 1/43 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/12 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.
Renal and urinary disorders Urinary retention	0.00% 0/6 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/17 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/21 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/40 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	2.3% 1/43 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/12 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/6 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/17 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	4.8% 1/21 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	10.0% 4/40 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	2.3% 1/43 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/12 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/6 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/17 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/21 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	5.0% 2/40 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	2.3% 1/43 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/12 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/6 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/17 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/21 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	2.5% 1/40 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/43 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/12 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/6 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	5.9% 1/17 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/21 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/40 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/43 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/12 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/6 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/17 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/21 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	2.5% 1/40 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/43 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/12 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.00% 0/6 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/17 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/21 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/40 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	2.3% 1/43 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/12 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.

Other adverse events

Other adverse events
Measure	Cohort 1 n=6 participants at risk enoblituzumab 3 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses.	Cohort 2 n=3 participants at risk enoblituzumab 10 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses.	Cohort 3 n=3 participants at risk enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses.	Melanoma Cohort n=17 participants at risk enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses.	Urothelial Cancer Cohort n=21 participants at risk enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses.	NSCLC Cohort n=40 participants at risk enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses.	SCCHN Cohort n=43 participants at risk enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses.	Cohort 4 n=12 participants at risk enoblituzumab 15 mg/kg IV and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses.
Blood and lymphatic system disorders Anaemia	0.00% 0/6 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	23.5% 4/17 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	14.3% 3/21 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	7.5% 3/40 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	16.3% 7/43 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	25.0% 3/12 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.
Endocrine disorders Hypothyroidism	0.00% 0/6 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/17 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	9.5% 2/21 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	10.0% 4/40 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	14.0% 6/43 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	8.3% 1/12 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.
Gastrointestinal disorders Nausea	0.00% 0/6 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	29.4% 5/17 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	19.0% 4/21 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	32.5% 13/40 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	20.9% 9/43 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	33.3% 4/12 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.
Gastrointestinal disorders Constipation	0.00% 0/6 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	41.2% 7/17 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	9.5% 2/21 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	10.0% 4/40 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	18.6% 8/43 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/12 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.
Gastrointestinal disorders Diarrhoea	0.00% 0/6 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	33.3% 1/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	17.6% 3/17 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	14.3% 3/21 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	22.5% 9/40 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	9.3% 4/43 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/12 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.
Gastrointestinal disorders Abdominal pain	0.00% 0/6 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	23.5% 4/17 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	19.0% 4/21 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	12.5% 5/40 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	9.3% 4/43 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/12 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.
Gastrointestinal disorders Vomiting	0.00% 0/6 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	33.3% 1/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	11.8% 2/17 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	19.0% 4/21 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	12.5% 5/40 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	9.3% 4/43 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/12 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.
General disorders Fatigue	33.3% 2/6 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	33.3% 1/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	66.7% 2/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	41.2% 7/17 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	19.0% 4/21 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	37.5% 15/40 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	44.2% 19/43 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	16.7% 2/12 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.
General disorders Pyrexia	0.00% 0/6 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	33.3% 1/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	23.5% 4/17 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	19.0% 4/21 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	5.0% 2/40 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	25.6% 11/43 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	16.7% 2/12 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.
General disorders Chills	16.7% 1/6 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	5.9% 1/17 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	9.5% 2/21 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	7.5% 3/40 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	11.6% 5/43 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/12 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.
General disorders Oedema peripheral	0.00% 0/6 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	17.6% 3/17 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	9.5% 2/21 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	5.0% 2/40 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	7.0% 3/43 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	8.3% 1/12 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.
Infections and infestations Urinary tract infection	0.00% 0/6 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	5.9% 1/17 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	28.6% 6/21 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/40 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	7.0% 3/43 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	8.3% 1/12 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.
Injury, poisoning and procedural complications Infusion related reaction	33.3% 2/6 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	33.3% 1/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	66.7% 2/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	52.9% 9/17 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	47.6% 10/21 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	60.0% 24/40 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	37.2% 16/43 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	50.0% 6/12 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.
Investigations Lipase increased	0.00% 0/6 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	11.8% 2/17 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	9.5% 2/21 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	15.0% 6/40 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	4.7% 2/43 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	8.3% 1/12 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.
Investigations Lymphocyte count decreased	0.00% 0/6 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/17 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	9.5% 2/21 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	2.5% 1/40 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	16.3% 7/43 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	8.3% 1/12 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.
Investigations Blood alkaline phosphatase increased	0.00% 0/6 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	5.9% 1/17 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	9.5% 2/21 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	2.5% 1/40 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	7.0% 3/43 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	8.3% 1/12 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/6 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	33.3% 1/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	11.8% 2/17 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	23.8% 5/21 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	27.5% 11/40 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	11.6% 5/43 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	25.0% 3/12 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/6 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	29.4% 5/17 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	19.0% 4/21 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/40 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	9.3% 4/43 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	16.7% 2/12 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/6 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	5.9% 1/17 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	14.3% 3/21 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	5.0% 2/40 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	11.6% 5/43 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	16.7% 2/12 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.
Metabolism and nutrition disorders Dehydration	0.00% 0/6 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	5.9% 1/17 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	9.5% 2/21 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	5.0% 2/40 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	16.3% 7/43 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/12 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/6 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	5.9% 1/17 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	14.3% 3/21 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	7.5% 3/40 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	7.0% 3/43 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/12 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/6 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	11.8% 2/17 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	4.8% 1/21 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	2.5% 1/40 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	9.3% 4/43 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	16.7% 2/12 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.
Metabolism and nutrition disorders Hypomagnesaemia	16.7% 1/6 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	17.6% 3/17 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	4.8% 1/21 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	2.5% 1/40 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	4.7% 2/43 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/12 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.
Musculoskeletal and connective tissue disorders Arthralgia	50.0% 3/6 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	33.3% 1/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	17.6% 3/17 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	38.1% 8/21 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	10.0% 4/40 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	18.6% 8/43 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/12 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.
Musculoskeletal and connective tissue disorders Back pain	16.7% 1/6 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	5.9% 1/17 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	9.5% 2/21 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	15.0% 6/40 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	9.3% 4/43 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	8.3% 1/12 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/6 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	33.3% 1/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	11.8% 2/17 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	19.0% 4/21 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	7.5% 3/40 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	7.0% 3/43 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/12 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.
Nervous system disorders Dizziness	0.00% 0/6 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	17.6% 3/17 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	9.5% 2/21 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	7.5% 3/40 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	14.0% 6/43 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/12 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.
Nervous system disorders Headache	0.00% 0/6 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	5.9% 1/17 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/21 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	2.5% 1/40 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	14.0% 6/43 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/12 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.
Psychiatric disorders Insomnia	16.7% 1/6 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	33.3% 1/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	5.9% 1/17 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	4.8% 1/21 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	12.5% 5/40 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	7.0% 3/43 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/12 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.
Renal and urinary disorders Haematuria	0.00% 0/6 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	5.9% 1/17 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	14.3% 3/21 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	7.5% 3/40 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	4.7% 2/43 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	16.7% 2/12 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.
Respiratory, thoracic and mediastinal disorders Cough	50.0% 3/6 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	33.3% 1/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	5.9% 1/17 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	19.0% 4/21 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	20.0% 8/40 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	16.3% 7/43 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	8.3% 1/12 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.
Respiratory, thoracic and mediastinal disorders Dyspnoea	33.3% 2/6 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	11.8% 2/17 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	9.5% 2/21 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	25.0% 10/40 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	11.6% 5/43 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	8.3% 1/12 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/6 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	5.9% 1/17 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	14.3% 3/21 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	2.5% 1/40 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	11.6% 5/43 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/12 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.
Skin and subcutaneous tissue disorders Rash maculo-papular	16.7% 1/6 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	33.3% 1/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	5.9% 1/17 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	9.5% 2/21 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	12.5% 5/40 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	2.3% 1/43 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	16.7% 2/12 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/6 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	33.3% 1/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	23.5% 4/17 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	4.8% 1/21 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	5.0% 2/40 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	7.0% 3/43 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	8.3% 1/12 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.
Skin and subcutaneous tissue disorders Rash	16.7% 1/6 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	33.3% 1/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	11.8% 2/17 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/21 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	5.0% 2/40 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	7.0% 3/43 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	16.7% 2/12 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.
Vascular disorders Hypotension	0.00% 0/6 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	11.8% 2/17 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	9.5% 2/21 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	10.0% 4/40 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	11.6% 5/43 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/12 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.
Vascular disorders Hypertension	0.00% 0/6 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/3 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	11.8% 2/17 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	4.8% 1/21 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	2.5% 1/40 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	11.6% 5/43 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.	0.00% 0/12 • Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months. Adverse event are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator. On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.

Additional Information

Chief Medical Officer

MacroGenics, Inc.

Phone: 301-251-5172

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60