Trial Outcomes & Findings for A Safety and Tolerability Study of NC410 in Subjects With Advanced or Metastatic Solid Tumors (NCT NCT04408599)

NCT ID: NCT04408599

Last Updated: 2024-07-25

Results Overview

Number of Participants With Treatment-emergent Adverse Events

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

46 participants

Primary outcome timeframe

From enrollment through up to 90 days after end of treatment, an average of 1 year

Results posted on

2024-07-25

Participant Flow

46 participants took part in the study at 5 investigative sites in the United States from 10Jun2020 to 06Jul2023.

Phase 1a (Dose Escalation) consisted of 7 planned cohorts (NC410 IV doses 3mg to 200mg). Phase 1b (Safety Expansion) consisted of 3 cohorts (NC410 IV doses 30mg , 60mg and 100mg). Phase 1 enrolled 46 participants. NextCure decided to forgoe moving forward with NC10 as a monotherapy in Phase 2.

Participant milestones

Participant milestones
Measure	NC410 3mg 3mg of NC410 for IV infusion administered in 14 day dosing cycles NC410: NC410 is an experimental antibody drug that may make the immune response more active against cancer	NC410 6mg 6mg of NC410 for IV infusion administered in 14 day dosing cycles NC410: NC410 is an experimental antibody drug that may make the immune response more active against cancer	NC410 15mg 15mg of NC410 for IV infusion administered in 14 day dosing cycles NC410: NC410 is an experimental antibody drug that may make the immune response more active against cancer	NC410 30mg 30mg of NC410 for IV infusion administered in 14 day dosing cycles NC410: NC410 is an experimental antibody drug that may make the immune response more active against cancer	NC410 60mg 60mg of NC410 for IV infusion administered in 14 day dosing cycles NC410: NC410 is an experimental antibody drug that may make the immune response more active against cancer	NC410 100mg 100mg of NC410 for IV infusion administered in 14 day dosing cycles NC410: NC410 is an experimental antibody drug that may make the immune response more active against cancer	NC410 200mg 200mg of NC410 for IV infusion administered in 14 day dosing cycles NC410: NC410 is an experimental antibody drug that may make the immune response more active against cancer
Overall Study STARTED	3	3	4	10	10	10	6
Overall Study COMPLETED	1	2	1	7	7	6	1
Overall Study NOT COMPLETED	2	1	3	3	3	4	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Safety and Tolerability Study of NC410 in Subjects With Advanced or Metastatic Solid Tumors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	NC410 3mg n=3 Participants 3mg of NC410 for IV infusion administered in 14 day dosing cycles NC410: NC410 is an experimental antibody drug that may make the immune response more active against cancer	NC410 6mg n=3 Participants 6mg of NC410 for IV infusion administered in 14 day dosing cycles NC410: NC410 is an experimental antibody drug that may make the immune response more active against cancer	NC410 15mg n=4 Participants 15mg of NC410 for IV infusion administered in 14 day dosing cycles NC410: NC410 is an experimental antibody drug that may make the immune response more active against cancer	NC410 30mg n=10 Participants 30mg of NC410 for IV infusion administered in 14 day dosing cycles NC410: NC410 is an experimental antibody drug that may make the immune response more active against cancer	NC410 60mg n=10 Participants 60mg of NC410 for IV infusion administered in 14 day dosing cycles NC410: NC410 is an experimental antibody drug that may make the immune response more active against cancer	NC410 100mg n=10 Participants 100mg of NC410 for IV infusion administered in 14 day dosing cycles NC410: NC410 is an experimental antibody drug that may make the immune response more active against cancer	NC410 200mg n=6 Participants 200mg of NC410 for IV infusion administered in 14 day dosing cycles NC410: NC410 is an experimental antibody drug that may make the immune response more active against cancer	Total n=46 Participants Total of all reporting groups
Age, Continuous	51.3 years STANDARD_DEVIATION 7.64 • n=5 Participants	61.3 years STANDARD_DEVIATION 13.32 • n=7 Participants	59.0 years STANDARD_DEVIATION 2.45 • n=5 Participants	58.2 years STANDARD_DEVIATION 14.44 • n=4 Participants	66.3 years STANDARD_DEVIATION 14.69 • n=21 Participants	59.3 years STANDARD_DEVIATION 9.46 • n=10 Participants	66.0 years STANDARD_DEVIATION 7.48 • n=115 Participants	61.0 years STANDARD_DEVIATION 11.77 • n=6 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	7 Participants n=4 Participants	3 Participants n=21 Participants	7 Participants n=10 Participants	5 Participants n=115 Participants	28 Participants n=6 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	7 Participants n=21 Participants	3 Participants n=10 Participants	1 Participants n=115 Participants	18 Participants n=6 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants	0 Participants n=115 Participants	3 Participants n=6 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	10 Participants n=4 Participants	10 Participants n=21 Participants	9 Participants n=10 Participants	5 Participants n=115 Participants	42 Participants n=6 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants	1 Participants n=6 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	1 Participants n=6 Participants
Race (NIH/OMB) Asian	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	0 Participants n=10 Participants	0 Participants n=115 Participants	1 Participants n=6 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=6 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants	4 Participants n=21 Participants	2 Participants n=10 Participants	1 Participants n=115 Participants	11 Participants n=6 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	5 Participants n=4 Participants	5 Participants n=21 Participants	7 Participants n=10 Participants	4 Participants n=115 Participants	30 Participants n=6 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	2 Participants n=6 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants	1 Participants n=6 Participants
Region of Enrollment United States	3 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	10 Participants n=4 Participants	10 Participants n=21 Participants	10 Participants n=10 Participants	6 Participants n=115 Participants	46 Participants n=6 Participants

PRIMARY outcome

Timeframe: From enrollment through up to 90 days after end of treatment, an average of 1 year

Population: The Safety Analysis Set (SAS) will include all the subjects who receive any amount of study drug.

Number of Participants With Treatment-emergent Adverse Events

Outcome measures

Outcome measures
Measure	NC410 3mg n=3 Participants 3mg of NC410 for IV infusion administered in 14 day dosing cycles NC410: NC410 is an experimental antibody drug that may make the immune response more active against cancer	NC410 6mg n=3 Participants 6mg of NC410 for IV infusion administered in 14 day dosing cycles NC410: NC410 is an experimental antibody drug that may make the immune response more active against cancer	NC410 15mg n=4 Participants 15mg of NC410 for IV infusion administered in 14 day dosing cycles NC410: NC410 is an experimental antibody drug that may make the immune response more active against cancer	NC410 30mg n=10 Participants 30mg of NC410 for IV infusion administered in 14 day dosing cycles NC410: NC410 is an experimental antibody drug that may make the immune response more active against cancer	NC410 60mg n=10 Participants 60mg of NC410 for IV infusion administered in 14 day dosing cycles NC410: NC410 is an experimental antibody drug that may make the immune response more active against cancer	NC410 100mg n=10 Participants 100mg of NC410 for IV infusion administered in 14 day dosing cycles NC410: NC410 is an experimental antibody drug that may make the immune response more active against cancer	NC410 200mg n=6 Participants 200mg of NC410 for IV infusion administered in 14 day dosing cycles NC410: NC410 is an experimental antibody drug that may make the immune response more active against cancer
Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0	3 Participants	3 Participants	4 Participants	9 Participants	10 Participants	9 Participants	6 Participants

SECONDARY outcome

Timeframe: Approximately 1 year

Population: The full analysis set (FAS) includes all subjects enrolled in the study who received at least one full dose of NC410.

To assess antitumor activity/efficacy by evaluating objective response rate (ORR), defined as the percentage of participants who experienced a complete response (CR; disappearance of all target lesions) or a partial response (PR; at least a 30% decrease in the sum of diameters of target lesions) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Outcome measures

Outcome measures
Measure	NC410 3mg n=3 Participants 3mg of NC410 for IV infusion administered in 14 day dosing cycles NC410: NC410 is an experimental antibody drug that may make the immune response more active against cancer	NC410 6mg n=3 Participants 6mg of NC410 for IV infusion administered in 14 day dosing cycles NC410: NC410 is an experimental antibody drug that may make the immune response more active against cancer	NC410 15mg n=4 Participants 15mg of NC410 for IV infusion administered in 14 day dosing cycles NC410: NC410 is an experimental antibody drug that may make the immune response more active against cancer	NC410 30mg n=10 Participants 30mg of NC410 for IV infusion administered in 14 day dosing cycles NC410: NC410 is an experimental antibody drug that may make the immune response more active against cancer	NC410 60mg n=10 Participants 60mg of NC410 for IV infusion administered in 14 day dosing cycles NC410: NC410 is an experimental antibody drug that may make the immune response more active against cancer	NC410 100mg n=10 Participants 100mg of NC410 for IV infusion administered in 14 day dosing cycles NC410: NC410 is an experimental antibody drug that may make the immune response more active against cancer	NC410 200mg n=6 Participants 200mg of NC410 for IV infusion administered in 14 day dosing cycles NC410: NC410 is an experimental antibody drug that may make the immune response more active against cancer
Objective Response Rate Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Approximately 1 year

Population: The full analysis set (FAS) includes all subjects enrolled in the study who received at least one full dose of NC410.

To assess antitumor activity/efficacy by evaluating duration of response (DoR), defined as the time from the first documented complete response or partial response per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or Modified Response Evaluation Criteria in Solid Tumors to the first documented progressive disease or death due to any cause, whichever occurs first. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: CompleteResponse (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions .

Outcome measures

Outcome measures
Measure	NC410 3mg n=3 Participants 3mg of NC410 for IV infusion administered in 14 day dosing cycles NC410: NC410 is an experimental antibody drug that may make the immune response more active against cancer	NC410 6mg n=3 Participants 6mg of NC410 for IV infusion administered in 14 day dosing cycles NC410: NC410 is an experimental antibody drug that may make the immune response more active against cancer	NC410 15mg n=4 Participants 15mg of NC410 for IV infusion administered in 14 day dosing cycles NC410: NC410 is an experimental antibody drug that may make the immune response more active against cancer	NC410 30mg n=10 Participants 30mg of NC410 for IV infusion administered in 14 day dosing cycles NC410: NC410 is an experimental antibody drug that may make the immune response more active against cancer	NC410 60mg n=10 Participants 60mg of NC410 for IV infusion administered in 14 day dosing cycles NC410: NC410 is an experimental antibody drug that may make the immune response more active against cancer	NC410 100mg n=10 Participants 100mg of NC410 for IV infusion administered in 14 day dosing cycles NC410: NC410 is an experimental antibody drug that may make the immune response more active against cancer	NC410 200mg n=6 Participants 200mg of NC410 for IV infusion administered in 14 day dosing cycles NC410: NC410 is an experimental antibody drug that may make the immune response more active against cancer
Duration of Response Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and Modified Response Evaluation Criteria in Solid Tumors	NA months Insufficient number of participants with events.	NA months Insufficient number of participants with events.	NA months Insufficient number of participants with events.	NA months Insufficient number of participants with events.	NA months Insufficient number of participants with events.	NA months Insufficient number of participants with events.	NA months Insufficient number of participants with events.

SECONDARY outcome

Timeframe: Approximately 1 year

Population: The FAS includes all subjects enrolled in the study who received at least one full dose of NC410

To assess antitumor activity/efficacy by evaluating disease control rate (DCR), defined as the proportion of participants in whom a documented complete response, partial response, or stable disease is observed as the best overall response per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

Outcome measures

Outcome measures
Measure	NC410 3mg n=3 Participants 3mg of NC410 for IV infusion administered in 14 day dosing cycles NC410: NC410 is an experimental antibody drug that may make the immune response more active against cancer	NC410 6mg n=3 Participants 6mg of NC410 for IV infusion administered in 14 day dosing cycles NC410: NC410 is an experimental antibody drug that may make the immune response more active against cancer	NC410 15mg n=4 Participants 15mg of NC410 for IV infusion administered in 14 day dosing cycles NC410: NC410 is an experimental antibody drug that may make the immune response more active against cancer	NC410 30mg n=10 Participants 30mg of NC410 for IV infusion administered in 14 day dosing cycles NC410: NC410 is an experimental antibody drug that may make the immune response more active against cancer	NC410 60mg n=10 Participants 60mg of NC410 for IV infusion administered in 14 day dosing cycles NC410: NC410 is an experimental antibody drug that may make the immune response more active against cancer	NC410 100mg n=10 Participants 100mg of NC410 for IV infusion administered in 14 day dosing cycles NC410: NC410 is an experimental antibody drug that may make the immune response more active against cancer	NC410 200mg n=6 Participants 200mg of NC410 for IV infusion administered in 14 day dosing cycles NC410: NC410 is an experimental antibody drug that may make the immune response more active against cancer
Disease Control Rate Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1	1 Participants	3 Participants	1 Participants	1 Participants	1 Participants	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Days 1, 2, 3 and 8 of Cycles 1 and 5. Each cycle is 14 days in duration.

Population: The PK analysis set (PAS) will include all the subjects whose blood samples are collected for PK analysis. One subject within NC410 100mg Arm/Group has been excluded from the summary table due to the day 1 pre-infusion and post-infusion concentration values being incorrect

To evaluate the Maximum Plasma Concentration (Cmax) of NC410

Outcome measures

Outcome measures
Measure	NC410 3mg 3mg of NC410 for IV infusion administered in 14 day dosing cycles NC410: NC410 is an experimental antibody drug that may make the immune response more active against cancer	NC410 6mg 6mg of NC410 for IV infusion administered in 14 day dosing cycles NC410: NC410 is an experimental antibody drug that may make the immune response more active against cancer	NC410 15mg n=4 Participants 15mg of NC410 for IV infusion administered in 14 day dosing cycles NC410: NC410 is an experimental antibody drug that may make the immune response more active against cancer	NC410 30mg n=10 Participants 30mg of NC410 for IV infusion administered in 14 day dosing cycles NC410: NC410 is an experimental antibody drug that may make the immune response more active against cancer	NC410 60mg n=10 Participants 60mg of NC410 for IV infusion administered in 14 day dosing cycles NC410: NC410 is an experimental antibody drug that may make the immune response more active against cancer	NC410 100mg n=9 Participants 100mg of NC410 for IV infusion administered in 14 day dosing cycles NC410: NC410 is an experimental antibody drug that may make the immune response more active against cancer	NC410 200mg n=6 Participants 200mg of NC410 for IV infusion administered in 14 day dosing cycles NC410: NC410 is an experimental antibody drug that may make the immune response more active against cancer
Maximum Plasma Concentration (Cmax) of NC410 Cycle 1	—	—	NA ng/mL Standard Deviation NA The mean and SD were below lower limit of detection	754 ng/mL Standard Deviation 295	2801 ng/mL Standard Deviation 1102	5296 ng/mL Standard Deviation 4405	11665 ng/mL Standard Deviation 9821
Maximum Plasma Concentration (Cmax) of NC410 Cycle 5	—	—	443 ng/mL Standard Deviation NA SD was below lower limit of detection	1490 ng/mL Standard Deviation 184	2200 ng/mL Standard Deviation NA SD was below lower limit of detection	2220 ng/mL Standard Deviation NA SD was below lower limit of detection	2880 ng/mL Standard Deviation NA SD was below lower limit of detection

SECONDARY outcome

Timeframe: Approximately 1 year

Population: The FAS includes all subjects enrolled in the study who received at least one full dose of NC410

To evaluate progression-free survival (PFS), defined as the time from the first dose of NC410 to the first occurrence of documented progressive disease or death due to any cause, whichever occurs first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), asa 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions .

Outcome measures

Outcome measures
Measure	NC410 3mg n=3 Participants 3mg of NC410 for IV infusion administered in 14 day dosing cycles NC410: NC410 is an experimental antibody drug that may make the immune response more active against cancer	NC410 6mg n=3 Participants 6mg of NC410 for IV infusion administered in 14 day dosing cycles NC410: NC410 is an experimental antibody drug that may make the immune response more active against cancer	NC410 15mg n=4 Participants 15mg of NC410 for IV infusion administered in 14 day dosing cycles NC410: NC410 is an experimental antibody drug that may make the immune response more active against cancer	NC410 30mg n=10 Participants 30mg of NC410 for IV infusion administered in 14 day dosing cycles NC410: NC410 is an experimental antibody drug that may make the immune response more active against cancer	NC410 60mg n=10 Participants 60mg of NC410 for IV infusion administered in 14 day dosing cycles NC410: NC410 is an experimental antibody drug that may make the immune response more active against cancer	NC410 100mg n=10 Participants 100mg of NC410 for IV infusion administered in 14 day dosing cycles NC410: NC410 is an experimental antibody drug that may make the immune response more active against cancer	NC410 200mg n=6 Participants 200mg of NC410 for IV infusion administered in 14 day dosing cycles NC410: NC410 is an experimental antibody drug that may make the immune response more active against cancer
Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and Modified Response Evaluation Criteria in Solid Tumors	1.7 Months Interval 1.6 to The upper limit of the confidence interval were not estimable due to limited number of participants with events.	3.6 Months Interval 3.6 to TThe upper limit of the confidence interval were not estimable due to limited number of participants with events.	1.3 Months Interval 0.5 to The upper limit of the confidence interval were not estimable due to limited number of participants with events.	1.7 Months Interval 1.0 to 3.5	1.4 Months Interval 1.0 to 1.7	1.4 Months Interval 1.2 to 1.8	1.8 Months Interval 1.2 to The upper limit of the confidence interval were not estimable due to limited number of participants with events.

SECONDARY outcome

Timeframe: Approximately 1 year

Population: The full analysis set (FAS) includes all subjects enrolled in the study who received at least one full dose of NC410.

To evaluate overall survival (OS), defined as the time from the first dose of NC410 to death due to any cause.

Outcome measures

Outcome measures
Measure	NC410 3mg n=3 Participants 3mg of NC410 for IV infusion administered in 14 day dosing cycles NC410: NC410 is an experimental antibody drug that may make the immune response more active against cancer	NC410 6mg n=3 Participants 6mg of NC410 for IV infusion administered in 14 day dosing cycles NC410: NC410 is an experimental antibody drug that may make the immune response more active against cancer	NC410 15mg n=4 Participants 15mg of NC410 for IV infusion administered in 14 day dosing cycles NC410: NC410 is an experimental antibody drug that may make the immune response more active against cancer	NC410 30mg n=10 Participants 30mg of NC410 for IV infusion administered in 14 day dosing cycles NC410: NC410 is an experimental antibody drug that may make the immune response more active against cancer	NC410 60mg n=10 Participants 60mg of NC410 for IV infusion administered in 14 day dosing cycles NC410: NC410 is an experimental antibody drug that may make the immune response more active against cancer	NC410 100mg n=10 Participants 100mg of NC410 for IV infusion administered in 14 day dosing cycles NC410: NC410 is an experimental antibody drug that may make the immune response more active against cancer	NC410 200mg n=6 Participants 200mg of NC410 for IV infusion administered in 14 day dosing cycles NC410: NC410 is an experimental antibody drug that may make the immune response more active against cancer
Overall Survival (OS) as Assessed by Time of Death	NA months Interval 7.6 to The median and upper limit of the confidence interval were not estimable due to limited number of participants with event.	5.3 months Interval 4.1 to The upper limit of the confidence interval was not estimable due to limited number of participants with event.	NA months The median and confidence intervals were not estimable due to limited number of participants with event.	NA months Interval 1.4 to The median and upper limit of the confidence interval were not estimable due to limited number of participants with event.	4.8 months Interval 1.0 to The upper limit of the confidence interval was not estimable due to limited number of participants with event.	NA months Interval 1.3 to The median and upper limit of the confidence interval were not estimable due to limited number of participants with event.	NA months Interval 1.2 to The median and upper limit of the confidence interval were not estimable due to limited number of participants with event.

SECONDARY outcome

Timeframe: Days 1, 2, 3 and 8 of Cycles 1 and 5. Each cycle is 14 days in duration.

Population: The PK analysis set (PAS) will include all the subjects whose blood samples are collected for PK analysis. AUC to Last Nonzero concentration.

To evaluate the Area Under the Curve (AUC) of NC410.

Outcome measures

Outcome measures
Measure	NC410 3mg 3mg of NC410 for IV infusion administered in 14 day dosing cycles NC410: NC410 is an experimental antibody drug that may make the immune response more active against cancer	NC410 6mg 6mg of NC410 for IV infusion administered in 14 day dosing cycles NC410: NC410 is an experimental antibody drug that may make the immune response more active against cancer	NC410 15mg n=4 Participants 15mg of NC410 for IV infusion administered in 14 day dosing cycles NC410: NC410 is an experimental antibody drug that may make the immune response more active against cancer	NC410 30mg n=10 Participants 30mg of NC410 for IV infusion administered in 14 day dosing cycles NC410: NC410 is an experimental antibody drug that may make the immune response more active against cancer	NC410 60mg n=10 Participants 60mg of NC410 for IV infusion administered in 14 day dosing cycles NC410: NC410 is an experimental antibody drug that may make the immune response more active against cancer	NC410 100mg n=10 Participants 100mg of NC410 for IV infusion administered in 14 day dosing cycles NC410: NC410 is an experimental antibody drug that may make the immune response more active against cancer	NC410 200mg n=6 Participants 200mg of NC410 for IV infusion administered in 14 day dosing cycles NC410: NC410 is an experimental antibody drug that may make the immune response more active against cancer
Area Under the Curve (AUC) of NC410 Cycle 1	—	—	—	13528 h*ng/mL Standard Deviation 15259	64530 h*ng/mL Standard Deviation 38613	107591 h*ng/mL Standard Deviation 52432	263894 h*ng/mL Standard Deviation 121831
Area Under the Curve (AUC) of NC410 Cycle 5	—	—	1056 h*ng/mL Standard Deviation NA Standard Deviation was below the lower limit of detection	47324 h*ng/mL Standard Deviation 3674	41448 h*ng/mL Standard Deviation NA Standard Deviation was below the lower limit of detection	205493 h*ng/mL Standard Deviation NA Standard Deviation was below the lower limit of detection	260199 h*ng/mL Standard Deviation NA Standard Deviation was below the lower limit of detection

SECONDARY outcome

Timeframe: Days 1, 2, 3 and 8 of Cycles 1 and 5. Each cycle is 14 days in duration.

Population: The PK analysis set (PAS) will include all the subjects whose blood samples are collected for PK analysis. Half-Life Lambda z (h).

To evaluate the half-life (t1/2) of NC410

Outcome measures

Outcome measures
Measure	NC410 3mg 3mg of NC410 for IV infusion administered in 14 day dosing cycles NC410: NC410 is an experimental antibody drug that may make the immune response more active against cancer	NC410 6mg 6mg of NC410 for IV infusion administered in 14 day dosing cycles NC410: NC410 is an experimental antibody drug that may make the immune response more active against cancer	NC410 15mg n=4 Participants 15mg of NC410 for IV infusion administered in 14 day dosing cycles NC410: NC410 is an experimental antibody drug that may make the immune response more active against cancer	NC410 30mg n=10 Participants 30mg of NC410 for IV infusion administered in 14 day dosing cycles NC410: NC410 is an experimental antibody drug that may make the immune response more active against cancer	NC410 60mg n=10 Participants 60mg of NC410 for IV infusion administered in 14 day dosing cycles NC410: NC410 is an experimental antibody drug that may make the immune response more active against cancer	NC410 100mg n=10 Participants 100mg of NC410 for IV infusion administered in 14 day dosing cycles NC410: NC410 is an experimental antibody drug that may make the immune response more active against cancer	NC410 200mg n=6 Participants 200mg of NC410 for IV infusion administered in 14 day dosing cycles NC410: NC410 is an experimental antibody drug that may make the immune response more active against cancer
Half-life (t1/2) of NC410 Cycle 1	—	—	—	75.7 hours Standard Deviation 74.7	126 hours Standard Deviation 52.0	173 hours Standard Deviation 43.6	111 hours Standard Deviation 53.8
Half-life (t1/2) of NC410 Cycle 5	—	—	—	138 hours Standard Deviation 7.23	41.1 hours Standard Deviation NA Standard Deviation was below the lower limit of detection	156 hours Standard Deviation NA Standard Deviation was below the lower limit of detection	194 hours Standard Deviation NA Standard Deviation was below the lower limit of detection

Adverse Events

NC410 3mg

Serious events: 1 serious events

Other events: 3 other events

Deaths: 1 deaths

NC410 6mg

Serious events: 3 serious events

Other events: 3 other events

Deaths: 2 deaths

NC410 15mg

Serious events: 2 serious events

Other events: 4 other events

Deaths: 0 deaths

NC410 30mg

Serious events: 5 serious events

Other events: 9 other events

Deaths: 2 deaths

NC410 60mg

Serious events: 5 serious events

Other events: 10 other events

Deaths: 4 deaths

NC410 100mg

Serious events: 7 serious events

Other events: 9 other events

Deaths: 3 deaths

NC410 200mg

Serious events: 3 serious events

Other events: 6 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	NC410 3mg n=3 participants at risk 3mg of NC410 for IV infusion administered in 14 day dosing cycles NC410: NC410 is an experimental antibody drug that may make the immune response more active against cancer	NC410 6mg n=3 participants at risk 6mg of NC410 for IV infusion administered in 14 day dosing cycles NC410: NC410 is an experimental antibody drug that may make the immune response more active against cancer	NC410 15mg n=4 participants at risk 15mg of NC410 for IV infusion administered in 14 day dosing cycles NC410: NC410 is an experimental antibody drug that may make the immune response more active against cancer	NC410 30mg n=10 participants at risk 30mg of NC410 for IV infusion administered in 14 day dosing cycles NC410: NC410 is an experimental antibody drug that may make the immune response more active against cancer	NC410 60mg n=10 participants at risk 60mg of NC410 for IV infusion administered in 14 day dosing cycles NC410: NC410 is an experimental antibody drug that may make the immune response more active against cancer	NC410 100mg n=10 participants at risk 100mg of NC410 for IV infusion administered in 14 day dosing cycles NC410: NC410 is an experimental antibody drug that may make the immune response more active against cancer	NC410 200mg n=6 participants at risk 200mg of NC410 for IV infusion administered in 14 day dosing cycles NC410: NC410 is an experimental antibody drug that may make the immune response more active against cancer
Blood and lymphatic system disorders Anaemia	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Cardiac disorders Cardiac arrest	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	33.3% 1/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Gastrointestinal disorders Ascites	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	33.3% 1/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Gastrointestinal disorders Pancreatitis	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	25.0% 1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
General disorders Disease Progression	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	16.7% 1/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
General disorders Non-cardiac chest pain	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Hepatobiliary disorders Biliary obstruction	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	33.3% 1/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	25.0% 1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	16.7% 1/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Hepatobiliary disorders Cholangitis acute	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	16.7% 1/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	16.7% 1/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Hepatobiliary disorders Hepatic Haemorrhage	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Immune system disorders Infusion Related Hypersensitivity reaction	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	16.7% 1/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Infections and infestations Sepsis	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	16.7% 1/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Infections and infestations Urinary tract infection	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	16.7% 1/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Injury, poisoning and procedural complications Fall	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Injury, poisoning and procedural complications Hip Fracture	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Metabolism and nutrition disorders Failure to Thrive	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Musculoskeletal and connective tissue disorders Arthralgia	33.3% 1/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal Cancer	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	33.3% 1/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Nervous system disorders Cerebral Ischaemia	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	33.3% 1/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Nervous system disorders Encephalopathy	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	33.3% 1/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Renal and urinary disorders Acute Kidney Injury	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	33.3% 1/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Respiratory, thoracic and mediastinal disorders Respiratory disorder	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Vascular disorders Embolism arterial	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.

Other adverse events

Other adverse events
Measure	NC410 3mg n=3 participants at risk 3mg of NC410 for IV infusion administered in 14 day dosing cycles NC410: NC410 is an experimental antibody drug that may make the immune response more active against cancer	NC410 6mg n=3 participants at risk 6mg of NC410 for IV infusion administered in 14 day dosing cycles NC410: NC410 is an experimental antibody drug that may make the immune response more active against cancer	NC410 15mg n=4 participants at risk 15mg of NC410 for IV infusion administered in 14 day dosing cycles NC410: NC410 is an experimental antibody drug that may make the immune response more active against cancer	NC410 30mg n=10 participants at risk 30mg of NC410 for IV infusion administered in 14 day dosing cycles NC410: NC410 is an experimental antibody drug that may make the immune response more active against cancer	NC410 60mg n=10 participants at risk 60mg of NC410 for IV infusion administered in 14 day dosing cycles NC410: NC410 is an experimental antibody drug that may make the immune response more active against cancer	NC410 100mg n=10 participants at risk 100mg of NC410 for IV infusion administered in 14 day dosing cycles NC410: NC410 is an experimental antibody drug that may make the immune response more active against cancer	NC410 200mg n=6 participants at risk 200mg of NC410 for IV infusion administered in 14 day dosing cycles NC410: NC410 is an experimental antibody drug that may make the immune response more active against cancer
Blood and lymphatic system disorders Anaemia	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	66.7% 2/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	50.0% 2/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	30.0% 3/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	60.0% 6/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	50.0% 5/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	33.3% 2/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	30.0% 3/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Cardiac disorders Cardiac arrest	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Cardiac disorders Conduction disorder	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Cardiac disorders Sinus bradycardia	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Cardiac disorders Tachycardia	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Endocrine disorders Hypothyroidism	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Eye disorders Eye pain	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Eye disorders Dry eye	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	33.3% 1/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	50.0% 2/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	20.0% 2/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	30.0% 3/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	20.0% 2/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	16.7% 1/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Gastrointestinal disorders Constipation	66.7% 2/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	33.3% 1/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	40.0% 4/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	20.0% 2/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	16.7% 1/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Gastrointestinal disorders Nausea	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	25.0% 1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	40.0% 4/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	40.0% 4/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	16.7% 1/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Gastrointestinal disorders Vomiting	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	50.0% 2/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	30.0% 3/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	66.7% 2/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	20.0% 2/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	33.3% 1/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	16.7% 1/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	25.0% 1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Gastrointestinal disorders Abdominal distension	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Gastrointestinal disorders Ascites	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	20.0% 2/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Gastrointestinal disorders Diarrhoea	33.3% 1/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Gastrointestinal disorders Dysphagia	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	16.7% 1/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Gastrointestinal disorders Abnormal faeces	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	16.7% 1/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Gastrointestinal disorders Colitis	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	16.7% 1/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Gastrointestinal disorders Large intestinal obstruction	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Gastrointestinal disorders Pancreatitis	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Gastrointestinal disorders Toothache	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
General disorders Fatigue	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	66.7% 2/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	25.0% 1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	20.0% 2/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
General disorders Non-cardiac chest pain	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	33.3% 1/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	20.0% 2/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	16.7% 1/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
General disorders Pyrexia	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	20.0% 2/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
General disorders Chills	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	20.0% 2/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
General disorders Disease progression	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	16.7% 1/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
General disorders Mucosal inflammation	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
General disorders Nodule	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
General disorders Oedema peripheral	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Hepatobiliary disorders Biliary obstruction	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	33.3% 1/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	25.0% 1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	16.7% 1/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Hepatobiliary disorders Cholangitis acute	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Hepatobiliary disorders Hepatic haemorrhage	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Immune system disorders Infusion related hypersensitivity reaction	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	16.7% 1/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Infections and infestations Urinary tract infection	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	30.0% 3/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	20.0% 2/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Infections and infestations Sepsis	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Infections and infestations COVID-19	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Infections and infestations Staphylococcal infection	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Infections and infestations Urosepsis	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	33.3% 2/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Injury, poisoning and procedural complications Contusion	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	16.7% 1/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Injury, poisoning and procedural complications Fall	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Injury, poisoning and procedural complications Stoma prolapse	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	16.7% 1/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Investigations Blood creatinine increased	33.3% 1/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	33.3% 1/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	25.0% 1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	20.0% 2/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	20.0% 2/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Investigations Alanine aminotransferase increased	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	33.3% 1/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	50.0% 2/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	30.0% 3/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Investigations Aspartate aminotransferase increased	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	33.3% 1/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	75.0% 3/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	20.0% 2/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Investigations Lipase increased	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	33.3% 1/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	50.0% 2/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Investigations Blood alkaline phosphatase increased	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	33.3% 1/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	25.0% 1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	20.0% 2/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Investigations Weight decreased	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	25.0% 1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	33.3% 2/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Investigations Amylase increased	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	33.3% 1/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Investigations Blood lactate dehydrogenase increased	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	25.0% 1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Investigations Platelet count decreased	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	25.0% 1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Investigations White blood cell count decreased	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	20.0% 2/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Investigations Blood bilirubin increased	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Investigations Electrocardiogram QT prolonged	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	20.0% 2/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Investigations Activated partial thromboplastin time prolonged	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Investigations Blood bilirubin decreased	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Investigations Blood uric acid increased	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Investigations Glomerular filtration rate decreased	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Investigations Neutrophil count decreased	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	33.3% 1/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	33.3% 1/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	50.0% 2/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	20.0% 2/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	30.0% 3/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	16.7% 1/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	33.3% 1/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	20.0% 2/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	40.0% 4/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	16.7% 1/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	33.3% 1/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	16.7% 1/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	33.3% 1/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	25.0% 1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	33.3% 1/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	20.0% 2/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Metabolism and nutrition disorders Hypomagnesaemia	33.3% 1/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	33.3% 1/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	20.0% 2/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Metabolism and nutrition disorders Hypophosphataemia	33.3% 1/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Metabolism and nutrition disorders Dehydration	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	33.3% 1/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	20.0% 2/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	33.3% 1/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Metabolism and nutrition disorders Hyperphosphataemia	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	25.0% 1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Metabolism and nutrition disorders Failure to thrive	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	33.3% 1/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Metabolism and nutrition disorders Hypernatraemia	33.3% 1/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	33.3% 1/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	20.0% 2/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	33.3% 2/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Musculoskeletal and connective tissue disorders Arthralgia	33.3% 1/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	25.0% 1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	16.7% 1/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	33.3% 1/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	20.0% 2/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	33.3% 1/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	25.0% 1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer fatigue	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal cancer	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	33.3% 1/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour haemorrhage	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Nervous system disorders Dizziness	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	33.3% 1/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	40.0% 4/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Nervous system disorders Headache	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	20.0% 2/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Nervous system disorders Cerebral ischaemia	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Nervous system disorders Encephalopathy	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	33.3% 1/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Nervous system disorders Peripheral motor neuropathy	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Psychiatric disorders Insomnia	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Psychiatric disorders Anxiety	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Renal and urinary disorders Haematuria	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	20.0% 2/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Renal and urinary disorders Acute kidney injury	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	33.3% 1/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Renal and urinary disorders Dysuria	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Renal and urinary disorders Proteinuria	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Renal and urinary disorders Urinary retention	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Reproductive system and breast disorders Pelvic pain	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	33.3% 2/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	33.3% 2/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	16.7% 1/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	16.7% 1/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Respiratory, thoracic and mediastinal disorders Bronchial obstruction	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Respiratory, thoracic and mediastinal disorders Painful respiration	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Respiratory, thoracic and mediastinal disorders Paranasal sinus discomfort	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Respiratory, thoracic and mediastinal disorders Respiratory disorder	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	16.7% 1/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	16.7% 1/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Skin and subcutaneous tissue disorders Eczema	33.3% 1/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	16.7% 1/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Skin and subcutaneous tissue disorders Nail disorder	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	16.7% 1/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Skin and subcutaneous tissue disorders Rash	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	25.0% 1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Vascular disorders Hypotension	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	20.0% 2/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.
Vascular disorders Embolism arterial	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	10.0% 1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.	0.00% 0/6 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have theoutcome noted as fatal.

Additional Information

Chief Medical Officer

NextCure, Inc

Phone: (240) 399-4900

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee PI cannot publish study results before the first multi-center publication. If a multi-center publication is not submitted within 12 months after the end of the study at all sites, or if Sponsor confirms there will be no multi-center publication, the PI may publish study results. However, PI will allow Sponsor at least 30 days to review any publication of study results and Sponsor may request an additional 60 days to review the publication.
Publication restrictions are in place

Restriction type: OTHER