Trial Outcomes & Findings for A Safety and Tolerability Study of NC762 in Subjects With Advanced or Metastatic Solid Tumors (NCT NCT04875806)

NCT ID: NCT04875806

Last Updated: 2025-04-22

Results Overview

Frequency, duration, and severity of treatment-emergent adverse events (AEs)

• Recruitment status: TERMINATED
• Study phase: PHASE1/PHASE2
• Target enrollment: 40 participants
• Primary outcome timeframe: From enrollment through up to 90 days after end of treatment, an average of 1 year
• Results posted on: 2025-04-22

Participant Flow

Participant milestones

Measure	0.5mg/kg NC762 Subjects received NC762 IV at 0.5mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer	1.5mg/kg NC762 Subjects received NC762 IV at 1.5mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer	5mg/kg NC762 Subjects received NC762 IV at 5mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer	10mg/kg NC762 Subjects received NC762 IV at 10mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer	20mg/kg NC762 Subjects received NC762 IV at 20mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer
Overall Study STARTED	4	4	3	11	18
Overall Study COMPLETED	3	2	2	5	13
Overall Study NOT COMPLETED	1	2	1	6	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

One participant in 10mg/kg cohort did not have baseline height collected, therefore baseline BMI could not be calculated.

Baseline characteristics by cohort

Measure	0.5mg/kg NC762 n=4 Participants Subjects received NC762 IV at 0.5mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer	1.5mg/kg NC762 n=4 Participants Subjects received NC762 IV at 1.5mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer	5mg/kg NC762 n=3 Participants Subjects received NC762 IV at 5mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer	10mg/kg NC762 n=11 Participants Subjects received NC762 IV at 10mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer	20mg/kg NC762 n=18 Participants Subjects received NC762 IV at 20mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer	Total n=40 Participants Total of all reporting groups
Age, Continuous	48.8 years STANDARD_DEVIATION 4.03 • n=4 Participants	74.0 years STANDARD_DEVIATION 8.76 • n=4 Participants	74.3 years STANDARD_DEVIATION 3.21 • n=3 Participants	61.5 years STANDARD_DEVIATION 13.13 • n=11 Participants	57.0 years STANDARD_DEVIATION 13.55 • n=18 Participants	60.4 years STANDARD_DEVIATION 13.62 • n=40 Participants
Sex: Female, Male Female	1 Participants n=4 Participants	1 Participants n=4 Participants	1 Participants n=3 Participants	7 Participants n=11 Participants	18 Participants n=18 Participants	28 Participants n=40 Participants
Sex: Female, Male Male	3 Participants n=4 Participants	3 Participants n=4 Participants	2 Participants n=3 Participants	4 Participants n=11 Participants	0 Participants n=18 Participants	12 Participants n=40 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=3 Participants	0 Participants n=11 Participants	1 Participants n=18 Participants	1 Participants n=40 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=4 Participants	4 Participants n=4 Participants	3 Participants n=3 Participants	11 Participants n=11 Participants	17 Participants n=18 Participants	39 Participants n=40 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=3 Participants	0 Participants n=11 Participants	0 Participants n=18 Participants	0 Participants n=40 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=3 Participants	0 Participants n=11 Participants	0 Participants n=18 Participants	0 Participants n=40 Participants
Race (NIH/OMB) Asian	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=3 Participants	0 Participants n=11 Participants	0 Participants n=18 Participants	0 Participants n=40 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=3 Participants	0 Participants n=11 Participants	0 Participants n=18 Participants	0 Participants n=40 Participants
Race (NIH/OMB) Black or African American	1 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=3 Participants	0 Participants n=11 Participants	3 Participants n=18 Participants	4 Participants n=40 Participants
Race (NIH/OMB) White	3 Participants n=4 Participants	4 Participants n=4 Participants	2 Participants n=3 Participants	11 Participants n=11 Participants	14 Participants n=18 Participants	34 Participants n=40 Participants
Race (NIH/OMB) More than one race	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=3 Participants	0 Participants n=11 Participants	0 Participants n=18 Participants	0 Participants n=40 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=4 Participants	0 Participants n=4 Participants	1 Participants n=3 Participants	0 Participants n=11 Participants	1 Participants n=18 Participants	2 Participants n=40 Participants
Region of Enrollment United States	4 participants n=4 Participants	4 participants n=4 Participants	3 participants n=3 Participants	11 participants n=11 Participants	18 participants n=18 Participants	40 participants n=40 Participants
Body Mass Index (BMI)	22.693 kg/m2 STANDARD_DEVIATION 4.6895 • n=4 Participants • One participant in 10mg/kg cohort did not have baseline height collected, therefore baseline BMI could not be calculated.	29.365 kg/m2 STANDARD_DEVIATION 4.2638 • n=4 Participants • One participant in 10mg/kg cohort did not have baseline height collected, therefore baseline BMI could not be calculated.	26.543 kg/m2 STANDARD_DEVIATION 4.5224 • n=3 Participants • One participant in 10mg/kg cohort did not have baseline height collected, therefore baseline BMI could not be calculated.	26.366 kg/m2 STANDARD_DEVIATION 5.5265 • n=10 Participants • One participant in 10mg/kg cohort did not have baseline height collected, therefore baseline BMI could not be calculated.	25.937 kg/m2 STANDARD_DEVIATION 6.0424 • n=18 Participants • One participant in 10mg/kg cohort did not have baseline height collected, therefore baseline BMI could not be calculated.	26.113 kg/m2 STANDARD_DEVIATION 5.4960 • n=39 Participants • One participant in 10mg/kg cohort did not have baseline height collected, therefore baseline BMI could not be calculated.

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.

Frequency, duration, and severity of treatment-emergent adverse events (AEs)

Outcome measures

Measure	0.5mg/kg NC762 n=4 Participants Subjects received NC762 IV at 0.5mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer	1.5mg/kg NC762 n=4 Participants Subjects received NC762 IV at 1.5mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer	5mg/kg NC762 n=3 Participants Subjects received NC762 IV at 5mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer	10mg/kg NC762 n=11 Participants Subjects received NC762 IV at 10mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer	20mg/kg NC762 n=18 Participants Subjects received NC762 IV at 20mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 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	4 Participants	3 Participants	3 Participants	11 Participants	18 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 NC762

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

Measure	0.5mg/kg NC762 n=4 Participants Subjects received NC762 IV at 0.5mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer	1.5mg/kg NC762 n=4 Participants Subjects received NC762 IV at 1.5mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer	5mg/kg NC762 n=3 Participants Subjects received NC762 IV at 5mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer	10mg/kg NC762 n=11 Participants Subjects received NC762 IV at 10mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer	20mg/kg NC762 n=18 Participants Subjects received NC762 IV at 20mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer
Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1	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 NC762

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 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: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions.

Outcome measures

Measure	0.5mg/kg NC762 n=4 Participants Subjects received NC762 IV at 0.5mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer	1.5mg/kg NC762 n=4 Participants Subjects received NC762 IV at 1.5mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer	5mg/kg NC762 n=3 Participants Subjects received NC762 IV at 5mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer	10mg/kg NC762 n=11 Participants Subjects received NC762 IV at 10mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer	20mg/kg NC762 n=18 Participants Subjects received NC762 IV at 20mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer
Duration of Response (DoR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1	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 NC762

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

Measure	0.5mg/kg NC762 n=4 Participants Subjects received NC762 IV at 0.5mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer	1.5mg/kg NC762 n=4 Participants Subjects received NC762 IV at 1.5mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer	5mg/kg NC762 n=3 Participants Subjects received NC762 IV at 5mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer	10mg/kg NC762 n=11 Participants Subjects received NC762 IV at 10mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer	20mg/kg NC762 n=18 Participants Subjects received NC762 IV at 20mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer
Disease Control Rate (DCR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1	2 Participants	3 Participants	2 Participants	3 Participants	6 Participants

SECONDARY outcome

Timeframe: Approximately 1 year

Population: The FAS includes all subjects enrolled in the study who received at least one full dose of NC762

To evaluate progression-free survival (PFS), defined as the time from the first dose of NC762 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), as a 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

Measure	0.5mg/kg NC762 n=4 Participants Subjects received NC762 IV at 0.5mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer	1.5mg/kg NC762 n=4 Participants Subjects received NC762 IV at 1.5mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer	5mg/kg NC762 n=3 Participants Subjects received NC762 IV at 5mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer	10mg/kg NC762 n=11 Participants Subjects received NC762 IV at 10mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer	20mg/kg NC762 n=18 Participants Subjects received NC762 IV at 20mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 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	12.07 weeks Interval 7.14 to The upper limit of the confidence interval were not estimable due to limited number of participants with events.	13.00 weeks Interval 7.86 to The upper limit of the confidence interval were not estimable due to limited number of participants with events.	33.29 weeks Interval 6.29 to The upper limit of the confidence interval were not estimable due to limited number of participants with events.	7.43 weeks Interval 6.29 to The upper limit of the confidence interval were not estimable due to limited number of participants with events.	7.57 weeks Interval 5.43 to 15.43

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 NC762

To evaluate overall survival (OS), defined as the time from the first dose of NC762 to death due to any cause.

Outcome measures

Measure	0.5mg/kg NC762 n=4 Participants Subjects received NC762 IV at 0.5mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer	1.5mg/kg NC762 n=4 Participants Subjects received NC762 IV at 1.5mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer	5mg/kg NC762 n=3 Participants Subjects received NC762 IV at 5mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer	10mg/kg NC762 n=11 Participants Subjects received NC762 IV at 10mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer	20mg/kg NC762 n=18 Participants Subjects received NC762 IV at 20mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer
Overall Survival (OS)	NA months Interval 2.86 to The median and upper limit of the confidence interval were not estimable due to limited number of participants with event.	15.74 months Confidence intervals were not estimable as survival curve hasn't reached a point where meaningful lower/upper limits can be estimated, due to limited follow-up and/or censoring.	7.66 months Interval 2.23 to The upper limit of the confidence interval was not estimable due to limited number of participants with event.	NA months Interval 2.92 to The median and upper limit of the confidence interval were not estimable due to limited number of participants with event.	7.92 months Interval 1.64 to The upper limit of the confidence interval was 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.

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

To evaluate the Maximum Serum Concentration (Cmax) of NC762

Outcome measures

Measure	0.5mg/kg NC762 n=4 Participants Subjects received NC762 IV at 0.5mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer	1.5mg/kg NC762 n=4 Participants Subjects received NC762 IV at 1.5mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer	5mg/kg NC762 n=2 Participants Subjects received NC762 IV at 5mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer	10mg/kg NC762 n=11 Participants Subjects received NC762 IV at 10mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer	20mg/kg NC762 n=16 Participants Subjects received NC762 IV at 20mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer
Maximum Serum Concentration (Cmax) of NC762 Cycle 1	11.2 ug/mL Standard Deviation 2.62	18.5 ug/mL Standard Deviation 4.98	119 ug/mL Standard Deviation 0.707	227 ug/mL Standard Deviation 69.6	440 ug/mL Standard Deviation 102
Maximum Serum Concentration (Cmax) of NC762 Cycle 5	14.6 ug/mL Standard Deviation 6.08	35.8 ug/mL Standard Deviation 6.21	NA ug/mL Standard Deviation NA Sample size too small (n=1) to calculate Mean and Standard Deviation at this visit. For each PK parameter, if at least 67% of the subjects had properly determined parameters (i.e., non-not reported \[NR\] and non-flagged), descriptive statistics were calculated. Otherwise, the descriptive statistics were replaced by NA.	289 ug/mL Standard Deviation 197	477 ug/mL Standard Deviation 163

SECONDARY outcome

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

Population: The PK analysis set (PAS) will include all the subjects whose blood samples are collected for PK analysis. AUC from time 0 to the last measurable concentration.

To evaluate the Area Under the Curve (AUC) of NC762

Outcome measures

Measure	0.5mg/kg NC762 n=4 Participants Subjects received NC762 IV at 0.5mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer	1.5mg/kg NC762 n=4 Participants Subjects received NC762 IV at 1.5mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer	5mg/kg NC762 n=2 Participants Subjects received NC762 IV at 5mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer	10mg/kg NC762 n=11 Participants Subjects received NC762 IV at 10mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer	20mg/kg NC762 n=16 Participants Subjects received NC762 IV at 20mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer
Area Under the Curve (AUC) of NC762 Cycle 1	1170 h*ug/mL Standard Deviation 439	2130 h*ug/mL Standard Deviation 481	13600 h*ug/mL Standard Deviation 2620	28300 h*ug/mL Standard Deviation 8990	47300 h*ug/mL Standard Deviation 13200
Area Under the Curve (AUC) of NC762 Cycle 5	2040 h*ug/mL Standard Deviation 976	5090 h*ug/mL Standard Deviation 684	NA h*ug/mL Standard Deviation NA Sample size too small (n=1) to calculate Mean and Standard Deviation at this visit. For each PK parameter, if at least 67% of the subjects had properly determined parameters (i.e., non-not reported \[NR\] and non-flagged), descriptive statistics were calculated. Otherwise, the descriptive statistics were replaced by NA.	39100 h*ug/mL Standard Deviation 38000	74900 h*ug/mL Standard Deviation 39100

SECONDARY outcome

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

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 NC762

Outcome measures

Measure	0.5mg/kg NC762 n=3 Participants Subjects received NC762 IV at 0.5mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer	1.5mg/kg NC762 n=2 Participants Subjects received NC762 IV at 1.5mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer	5mg/kg NC762 n=2 Participants Subjects received NC762 IV at 5mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer	10mg/kg NC762 n=4 Participants Subjects received NC762 IV at 10mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer	20mg/kg NC762 n=8 Participants Subjects received NC762 IV at 20mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer
Half-life (T1/2) of NC762 Cycle 1	114 h Standard Deviation 23.8	131 h Standard Deviation 29	129 h Standard Deviation 12	124 h Standard Deviation 24.5	129 h Standard Deviation 20.5
Half-life (T1/2) of NC762 Cycle 5	—	—	NA h Standard Deviation NA Sample size to small (n=1) to calculate Mean and Standard Deviation at this visit. For each PK parameter, if at least 67% of the subjects had properly determined parameters (i.e., non-not reported \[NR\] and non-flagged), descriptive statistics were calculated. Otherwise, the descriptive statistics were replaced by NA.	NA h Standard Deviation NA Sample size to small (n=1) to calculate Mean and Standard Deviation at this visit. For each PK parameter, if at least 67% of the subjects had properly determined parameters (i.e., non-not reported \[NR\] and non-flagged), descriptive statistics were calculated. Otherwise, the descriptive statistics were replaced by NA.	NA h Standard Deviation NA Sample size to small (n=1) to calculate Mean and Standard Deviation at this visit. For each PK parameter, if at least 67% of the subjects had properly determined parameters (i.e., non-not reported \[NR\] and non-flagged), descriptive statistics were calculated. Otherwise, the descriptive statistics were replaced by NA.

Adverse Events

0.5mg/kg NC762

Serious events: 0 serious events

Other events: 4 other events

Deaths: 1 deaths

1.5mg/kg NC762

Serious events: 0 serious events

Other events: 3 other events

Deaths: 1 deaths

5mg/kg NC762

Serious events: 1 serious events

Other events: 3 other events

Deaths: 2 deaths

10mg/kg NC762

Serious events: 1 serious events

Other events: 11 other events

Deaths: 2 deaths

20mg/kg NC762

Serious events: 11 serious events

Other events: 17 other events

Deaths: 9 deaths

Serious adverse events

Measure	0.5mg/kg NC762 n=4 participants at risk Subjects received NC762 IV at 0.5mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer	1.5mg/kg NC762 n=4 participants at risk Subjects received NC762 IV at 1.5mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer	5mg/kg NC762 n=3 participants at risk Subjects received NC762 IV at 5mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer	10mg/kg NC762 n=11 participants at risk Subjects received NC762 IV at 10mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer	20mg/kg NC762 n=18 participants at risk Subjects received NC762 IV at 20mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer
Respiratory, thoracic and mediastinal disorders Pneumothorax	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 the outcome 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 the outcome noted as fatal.	33.3% 1/3 • Number of events 1 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	0.00% 0/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Renal and urinary disorders Acute Kidney Injury	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 the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	5.6% 1/18 • Number of events 1 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Gastrointestinal disorders Abdominal Pain	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 the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	11.1% 2/18 • Number of events 3 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Nervous system disorders Encephalopathy	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 the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	11.1% 2/18 • Number of events 2 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Infections and infestations Sepsis	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 the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	5.6% 1/18 • Number of events 1 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Blood and lymphatic system disorders Disseminated Intravascular Coagulation	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 the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	5.6% 1/18 • Number of events 1 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Gastrointestinal disorders Abdominal Distension	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 the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	5.6% 1/18 • Number of events 1 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	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 the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	5.6% 1/18 • Number of events 1 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Nervous system disorders Spinal Cord Compression	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 the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	5.6% 1/18 • Number of events 1 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Psychiatric disorders Mental Status Change	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 the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	5.6% 1/18 • Number of events 1 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Gastrointestinal disorders Nausea	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 the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	5.6% 1/18 • Number of events 1 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Gastrointestinal disorders Vomitting	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 the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	5.6% 1/18 • Number of events 1 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Infections and infestations Pneumonia	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 the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	5.6% 1/18 • Number of events 1 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Gastrointestinal disorders Small Intestinal Obstruction	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 the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	5.6% 1/18 • Number of events 1 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Gastrointestinal disorders Ascites	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 the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	11.1% 2/18 • Number of events 2 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant Ascites	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 the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	5.6% 1/18 • Number of events 1 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.

Other adverse events

Measure	0.5mg/kg NC762 n=4 participants at risk Subjects received NC762 IV at 0.5mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer	1.5mg/kg NC762 n=4 participants at risk Subjects received NC762 IV at 1.5mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer	5mg/kg NC762 n=3 participants at risk Subjects received NC762 IV at 5mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer	10mg/kg NC762 n=11 participants at risk Subjects received NC762 IV at 10mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer	20mg/kg NC762 n=18 participants at risk Subjects received NC762 IV at 20mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer
Metabolism and nutrition disorders Dehydration	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 the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	0.00% 0/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Blood and lymphatic system disorders Anaemia	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 the outcome 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 the outcome 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 the outcome noted as fatal.	45.5% 5/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	22.2% 4/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Blood and lymphatic system disorders Leukocytosis	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 the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	5.6% 1/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Blood and lymphatic system disorders Leukopenia	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 the outcome 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 the outcome 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 the outcome noted as fatal.	9.1% 1/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	0.00% 0/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Blood and lymphatic system disorders Neutropenia	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 the outcome 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 the outcome 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 the outcome noted as fatal.	9.1% 1/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	0.00% 0/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Cardiac disorders Palpitations	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 the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	5.6% 1/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Cardiac disorders Sinus tachycardia	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 the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	11.1% 2/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Cardiac disorders Tachycardia	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 the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	16.7% 3/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Metabolism and nutrition disorders Hypercalcaemia	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 the outcome 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 the outcome 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 the outcome noted as fatal.	9.1% 1/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	5.6% 1/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Ear and labyrinth disorders Ear Pain	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 the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	0.00% 0/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Endocrine disorders Hypothyroidism	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 the outcome 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 the outcome 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 the outcome noted as fatal.	9.1% 1/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	0.00% 0/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Gastrointestinal disorders Abdominal discomfort	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 the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	5.6% 1/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Gastrointestinal disorders Abdominal distension	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 the outcome 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 the outcome 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 the outcome noted as fatal.	9.1% 1/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	11.1% 2/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Gastrointestinal disorders Abdominal pain	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 the outcome 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 the outcome 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 the outcome noted as fatal.	27.3% 3/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	33.3% 6/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Gastrointestinal disorders Abdominal pain lower	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 the outcome 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 the outcome 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 the outcome noted as fatal.	9.1% 1/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	0.00% 0/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Gastrointestinal disorders Abdominal pain upper	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 the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	11.1% 2/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Gastrointestinal disorders Constipation	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 the outcome 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 the outcome 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 the outcome noted as fatal.	18.2% 2/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	33.3% 6/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Gastrointestinal disorders Diarrhoea	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 the outcome 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 the outcome 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 the outcome noted as fatal.	9.1% 1/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	16.7% 3/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Gastrointestinal disorders Dry mouth	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 the outcome 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 the outcome 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 the outcome noted as fatal.	9.1% 1/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	0.00% 0/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Gastrointestinal disorders Dyspepsia	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 the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	5.6% 1/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Gastrointestinal disorders Gastrointestinal pain	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 the outcome 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 the outcome 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 the outcome noted as fatal.	9.1% 1/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	0.00% 0/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Gastrointestinal disorders Gastroesophageal reflux disease	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 the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	5.6% 1/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Gastrointestinal disorders Nausea	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 the outcome 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 the outcome 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 the outcome noted as fatal.	36.4% 4/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	33.3% 6/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Gastrointestinal disorders Pancreatic mass	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 the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	0.00% 0/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Gastrointestinal disorders Proctalgia	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 the outcome 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 the outcome 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 the outcome noted as fatal.	9.1% 1/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	0.00% 0/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Gastrointestinal disorders Vomiting	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 the outcome 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 the outcome 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 the outcome noted as fatal.	9.1% 1/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	33.3% 6/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
General disorders Chest pain	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 the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	0.00% 0/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
General disorders Fatigue	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 the outcome 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 the outcome 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 the outcome noted as fatal.	36.4% 4/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	27.8% 5/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
General disorders Feeling jittery	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 the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	0.00% 0/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
General disorders Hypothermia	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 the outcome 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 the outcome 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 the outcome noted as fatal.	9.1% 1/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	0.00% 0/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
General disorders Influenza like illness	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 the outcome 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 the outcome 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 the outcome noted as fatal.	9.1% 1/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	0.00% 0/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
General disorders Localised oedema	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 the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	5.6% 1/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
General disorders Malaise	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 the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	5.6% 1/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
General disorders Non-cardia chest pain	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 the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	11.1% 2/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
General disorders Oedema peripheral	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 the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	11.1% 2/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
General disorders Pain	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 the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	5.6% 1/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
General disorders Pyrexia	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 the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	5.6% 1/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Immune system disorders Hypersensitivity	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 the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	5.6% 1/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Infections and infestations Bronchitis	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 the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	0.00% 0/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Infections and infestations COVID-19	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 the outcome 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 the outcome 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 the outcome noted as fatal.	9.1% 1/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	0.00% 0/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Infections and infestations Respiratory syncytial virus infection	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 the outcome 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 the outcome 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 the outcome noted as fatal.	9.1% 1/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	0.00% 0/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Infections and infestations Sinusitis	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 the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	0.00% 0/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Infections and infestations Upper respiratory tract infection	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 the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	5.6% 1/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Infections and infestations Urinary tract infection	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 the outcome 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 the outcome 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 the outcome noted as fatal.	9.1% 1/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	16.7% 3/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Injury, poisoning and procedural complications Contusion	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 the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	0.00% 0/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Injury, poisoning and procedural complications Facial bone fracture	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 the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	5.6% 1/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Injury, poisoning and procedural complications Fall	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 the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	5.6% 1/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Injury, poisoning and procedural complications Infusion related reaction	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 the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	5.6% 1/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Injury, poisoning and procedural complications Radiation skin injury	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 the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	5.6% 1/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Investigations Activated partial thromboplastin time prolonged	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 the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	5.6% 1/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Investigations Alanine aminotransferase increased	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 the outcome 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 the outcome 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 the outcome noted as fatal.	18.2% 2/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	5.6% 1/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Investigations Ammonia increased	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 the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	5.6% 1/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Investigations Amylase increased	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 the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	5.6% 1/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Investigations Aspartate aminotransferase increased	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 the outcome 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 the outcome 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 the outcome noted as fatal.	27.3% 3/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	11.1% 2/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Investigations Blood alkaline phosphatase increased	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 the outcome 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 the outcome 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 the outcome noted as fatal.	9.1% 1/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	16.7% 3/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Investigations Blood bilirubin increased	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 the outcome 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 the outcome 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 the outcome noted as fatal.	9.1% 1/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	11.1% 2/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Investigations Blood creatinine increased	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 the outcome 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 the outcome 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 the outcome noted as fatal.	18.2% 2/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	22.2% 4/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Investigations Blood folate decreased	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 the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	5.6% 1/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Investigations Blood lactate dehydrogenase increased	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 the outcome 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 the outcome 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 the outcome noted as fatal.	18.2% 2/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	5.6% 1/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Investigations Blood lactic acid increased	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 the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	11.1% 2/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Investigations Carbon dioxide increased	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 the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	5.6% 1/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Investigations Haemoglobin decreased	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 the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	5.6% 1/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Investigations International normalised ratio increased	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 the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	11.1% 2/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Investigations Lipase increased	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 the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	5.6% 1/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Investigations Lymphocyte count decreased	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 the outcome 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 the outcome 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 the outcome noted as fatal.	9.1% 1/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	33.3% 6/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Investigations Neutrophil count decreased	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 the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	5.6% 1/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Investigations Platelet count decreased	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 the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	16.7% 3/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Investigations Red blood cell count decreased	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 the outcome 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 the outcome 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 the outcome noted as fatal.	9.1% 1/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	0.00% 0/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Investigations Troponin I increased	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 the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	5.6% 1/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Investigations Troponin increased	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 the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	5.6% 1/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Investigations Weight decreased	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 the outcome 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 the outcome 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 the outcome noted as fatal.	18.2% 2/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	5.6% 1/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Investigations White blood cell count decreased	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 the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	11.1% 2/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Investigations White blood cell count increased	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 the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	5.6% 1/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Metabolism and nutrition disorders Decreased appetite	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 the outcome 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 the outcome 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 the outcome noted as fatal.	9.1% 1/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	5.6% 1/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Metabolism and nutrition disorders Hyperglycaemia	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 the outcome 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 the outcome 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 the outcome noted as fatal.	9.1% 1/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	11.1% 2/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Metabolism and nutrition disorders Hypermagnesaemia	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 the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	5.6% 1/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Metabolism and nutrition disorders Hypernatraemia	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 the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	5.6% 1/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Metabolism and nutrition disorders Hyperphosphataemia	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 the outcome 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 the outcome 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 the outcome noted as fatal.	9.1% 1/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	5.6% 1/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Metabolism and nutrition disorders Hypoalbuminaemia	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 the outcome 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 the outcome 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 the outcome noted as fatal.	18.2% 2/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	11.1% 2/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Metabolism and nutrition disorders Hypocalcaemia	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 the outcome 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 the outcome 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 the outcome noted as fatal.	9.1% 1/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	16.7% 3/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Metabolism and nutrition disorders Hypokalaemia	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 the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	16.7% 3/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Metabolism and nutrition disorders Hypomagnesaemia	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 the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	11.1% 2/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Metabolism and nutrition disorders Hyponatraemia	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 the outcome 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 the outcome 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 the outcome noted as fatal.	27.3% 3/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	16.7% 3/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Metabolism and nutrition disorders Hypophosphataemia	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 the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	16.7% 3/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Musculoskeletal and connective tissue disorders Arthralgia	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 the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	5.6% 1/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Musculoskeletal and connective tissue disorders Arthritis	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 the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	0.00% 0/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Musculoskeletal and connective tissue disorders Back pain	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 the outcome 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 the outcome 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 the outcome noted as fatal.	18.2% 2/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	5.6% 1/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Musculoskeletal and connective tissue disorders Bone pain	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 the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	0.00% 0/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Musculoskeletal and connective tissue disorders Flank pain	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 the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	0.00% 0/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Musculoskeletal and connective tissue disorders Groin pain	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 the outcome 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 the outcome 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 the outcome noted as fatal.	9.1% 1/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	0.00% 0/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Musculoskeletal and connective tissue disorders Joint swelling	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 the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	5.6% 1/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Musculoskeletal and connective tissue disorders Muscular weakness	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 the outcome 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 the outcome 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 the outcome noted as fatal.	9.1% 1/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	5.6% 1/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Musculoskeletal and connective tissue disorders Myalgia	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 the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	0.00% 0/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Musculoskeletal and connective tissue disorders Pain in extremity	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 the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	5.6% 1/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	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 the outcome 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 the outcome 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 the outcome noted as fatal.	9.1% 1/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	0.00% 0/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Nervous system disorders Aphasia	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 the outcome 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 the outcome 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 the outcome noted as fatal.	9.1% 1/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	0.00% 0/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Nervous system disorders Cognitive disorder	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 the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	5.6% 1/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Nervous system disorders Headache	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 the outcome 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 the outcome 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 the outcome noted as fatal.	18.2% 2/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	5.6% 1/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Nervous system disorders Lethargy	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 the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	5.6% 1/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Nervous system disorders Presyncope	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 the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	5.6% 1/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Nervous system disorders Sciatica	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 the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	0.00% 0/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Nervous system disorders Somnolence	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 the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	5.6% 1/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Nervous system disorders Vocal cord paralysis	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 the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	5.6% 1/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Psychiatric disorders Abnormal dreams	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 the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	0.00% 0/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Psychiatric disorders Anxiety	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 the outcome 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 the outcome noted as fatal.	— 0/0 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	9.1% 1/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	5.6% 1/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Psychiatric disorders Confusional state	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 the outcome 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 the outcome noted as fatal.	0.00% 0/1 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	9.1% 1/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	5.6% 1/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Psychiatric disorders Depression	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 the outcome 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 the outcome noted as fatal.	— 0/0 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	0.00% 0/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Psychiatric disorders Insomnia	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 the outcome 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 the outcome noted as fatal.	— 0/0 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	0.00% 0/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Psychiatric disorders Mental status changes	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 the outcome 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 the outcome noted as fatal.	— 0/0 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	9.1% 1/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	5.6% 1/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Renal and urinary disorders Acute kidney injury	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 the outcome noted as fatal.	— 0/0 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	5.6% 1/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Renal and urinary disorders Haematuria	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 the outcome noted as fatal.	— 0/0 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	0.00% 0/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Renal and urinary disorders Pollakiuria	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 the outcome noted as fatal.	— 0/0 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	5.6% 1/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Renal and urinary disorders Proteinuria	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 the outcome noted as fatal.	— 0/0 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome 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 the outcome noted as fatal.	9.1% 1/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	0.00% 0/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Renal and urinary disorders Urinary incontinence	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 the outcome noted as fatal.	— 0/0 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	11.1% 2/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Renal and urinary disorders Urinary retention	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 the outcome noted as fatal.	— 0/0 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	5.6% 1/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Reproductive system and breast disorders Pelvic pain	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 the outcome 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 the outcome 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 the outcome noted as fatal.	9.1% 1/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	0.00% 0/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Respiratory, thoracic and mediastinal disorders Cough	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 the outcome 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 the outcome 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 the outcome noted as fatal.	9.1% 1/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	11.1% 2/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Respiratory, thoracic and mediastinal disorders Dyspnoea	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 the outcome 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 the outcome 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 the outcome noted as fatal.	18.2% 2/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	11.1% 2/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	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 the outcome 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 the outcome 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 the outcome noted as fatal.	9.1% 1/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	0.00% 0/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Respiratory, thoracic and mediastinal disorders Epistaxis	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 the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	5.6% 1/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Respiratory, thoracic and mediastinal disorders Hypoxia	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 the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	11.1% 2/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Respiratory, thoracic and mediastinal disorders Nasal congestion	— 0/0 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome 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 the outcome 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 the outcome noted as fatal.	9.1% 1/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	5.6% 1/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Respiratory, thoracic and mediastinal disorders Pleural effusion	— 0/0 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	11.1% 2/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Respiratory, thoracic and mediastinal disorders Pneumonitis	— 0/0 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	5.6% 1/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Respiratory, thoracic and mediastinal disorders Pneumothorax	— 0/0 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	0.00% 0/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Respiratory, thoracic and mediastinal disorders Respiratory failure	— 0/0 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	5.6% 1/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	— 0/0 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	5.6% 1/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Respiratory, thoracic and mediastinal disorders Wheezing	— 0/0 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome 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 the outcome 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 the outcome noted as fatal.	9.1% 1/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	5.6% 1/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Skin and subcutaneous tissue disorders Alopecia	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 the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	5.6% 1/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Skin and subcutaneous tissue disorders Ecchymosis	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 the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	5.6% 1/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Skin and subcutaneous tissue disorders Hyperhidrosis	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 the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	5.6% 1/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Skin and subcutaneous tissue disorders Night sweats	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 the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	0.00% 0/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Skin and subcutaneous tissue disorders Pruritus	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 the outcome 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 the outcome 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 the outcome noted as fatal.	9.1% 1/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	11.1% 2/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Skin and subcutaneous tissue disorders Rash	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 the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	5.6% 1/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Skin and subcutaneous tissue disorders Rash maculo-papular	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 the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	0.00% 0/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Vascular disorders Flushing	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 the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	0.00% 0/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Vascular disorders Hypertension	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 the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	11.1% 2/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Vascular disorders Hypotension	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 the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	5.6% 1/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
Vascular disorders Ischaemia	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 the outcome 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 the outcome 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 the outcome noted as fatal.	0.00% 0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.	5.6% 1/18 • From enrollment through up to 90 days after end of treatment, an average of 1 year. The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.

Additional Information

Senior VP, Clinical and Translational Development

NextCure, Inc

Phone: 240-399-4900

Email: NCClin@nextcure.com

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