Trial Outcomes & Findings for Avelumab and Trabectedin in Treating Patients With Liposarcoma or Leiomyosarcoma That is Metastatic or Cannot Be Removed by Surgery (NCT NCT03074318)

NCT ID: NCT03074318

Last Updated: 2022-04-29

Results Overview

Measured by Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0.

• Recruitment status: TERMINATED
• Study phase: PHASE1/PHASE2
• Target enrollment: 35 participants
• Primary outcome timeframe: up to 2 years 7 months total
• Results posted on: 2022-04-29

Participant Flow

Participant milestones

Measure	Phase 1 Dose Level 1 Subjects received 1.5 mg/m\^2 of trabectedin plus avelumab.	Phase 1 Dose Level 2 Subjects received 1.0 mg/m\^2 of trabectedin plus avelumab	Phase 1 Dose Level 3 Subjects received 1.2 mg/m\^2 of trabectedin plus avelumab.	Phase 2 Subjects received 1.0 mg/m\^2 trabectedin plus avelumab.
Overall Study STARTED	6	7	6	16
Overall Study COMPLETED	2	2	0	0
Overall Study NOT COMPLETED	4	5	6	16

Reasons for withdrawal

Measure	Phase 1 Dose Level 1 Subjects received 1.5 mg/m\^2 of trabectedin plus avelumab.	Phase 1 Dose Level 2 Subjects received 1.0 mg/m\^2 of trabectedin plus avelumab	Phase 1 Dose Level 3 Subjects received 1.2 mg/m\^2 of trabectedin plus avelumab.	Phase 2 Subjects received 1.0 mg/m\^2 trabectedin plus avelumab.
Overall Study Adverse Event	0	1	1	1
Overall Study Death	1	0	0	0
Overall Study Withdrawal by Subject	1	2	2	4
Overall Study Trial Closure	2	2	3	11

Baseline Characteristics

Avelumab and Trabectedin in Treating Patients With Liposarcoma or Leiomyosarcoma That is Metastatic or Cannot Be Removed by Surgery

Baseline characteristics by cohort

Measure	Phase 1 (1.5 mg/m^2 Trabectedin) n=6 Participants Phase 1: Avelumab will be administered every 2 weeks. Trabectedin will be administered every 3 weeks for the first two doses (Week 1 and Week 4), and then every four weeks (Week 7, Week 11,…) moving forward. After Cycle 2 of trabectedin, dosing may extend to every 5 weeks at investigator discretion, for management of trabectedin-associated toxicity only. Delays of trabectedin beyond 5 weeks may be allowed but require written approval from the Sponsor-Investigator. On days where both drugs are scheduled to be administered, avelumab will be administered first. This will continue until unacceptable toxicity or confirmed disease progression. Avelumab: Given IV Trabectedin: Given IV	Phase 1 (1.0 mg/m^2 Trabectedin) n=7 Participants Phase 1: Avelumab will be administered every 2 weeks. Trabectedin will be administered every 3 weeks for the first two doses (Week 1 and Week 4), and then every four weeks (Week 7, Week 11,…) moving forward. After Cycle 2 of trabectedin, dosing may extend to every 5 weeks at investigator discretion, for management of trabectedin-associated toxicity only. Delays of trabectedin beyond 5 weeks may be allowed but require written approval from the Sponsor-Investigator. On days where both drugs are scheduled to be administered, avelumab will be administered first. This will continue until unacceptable toxicity or confirmed disease progression. Avelumab: Given IV Trabectedin: Given IV	Phase 1 (1.2 mg/m^2 Trabectedin) n=6 Participants Phase 1: Avelumab will be administered every 2 weeks. Trabectedin will be administered every 3 weeks for the first two doses (Week 1 and Week 4), and then every four weeks (Week 7, Week 11,…) moving forward. After Cycle 2 of trabectedin, dosing may extend to every 5 weeks at investigator discretion, for management of trabectedin-associated toxicity only. Delays of trabectedin beyond 5 weeks may be allowed but require written approval from the Sponsor-Investigator. On days where both drugs are scheduled to be administered, avelumab will be administered first. This will continue until unacceptable toxicity or confirmed disease progression. Avelumab: Given IV Trabectedin: Given IV	Phase 2 (Avelumab, Trabectedin) n=16 Participants Phase 2: Avelumab will be administered every 2 weeks. Trabectedin will be administered every 3 weeks for the first two doses (Week 1 and Week 4), and then every four weeks (Week 7, Week 11,…) moving forward. After Cycle 2 of trabectedin, dosing may extend to every 5 weeks at investigator discretion, for management of trabectedin-associated toxicity only. Delays of trabectedin beyond 5 weeks may be allowed but require written approval from the Sponsor-Investigator. On days where both drugs are scheduled to be administered, avelumab will be administered first. This will continue until unacceptable toxicity or confirmed disease progression. Avelumab: Given IV Trabectedin: Given IV	Total n=35 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants	7 Participants n=7 Participants	4 Participants n=5 Participants	7 Participants n=4 Participants	22 Participants n=21 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	9 Participants n=4 Participants	13 Participants n=21 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	5 Participants n=7 Participants	3 Participants n=5 Participants	11 Participants n=4 Participants	20 Participants n=21 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	5 Participants n=4 Participants	15 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants	7 Participants n=7 Participants	6 Participants n=5 Participants	14 Participants n=4 Participants	33 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	4 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants	12 Participants n=4 Participants	27 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants
Type of Sarcoma Uterine Leiomyosarcoma	0 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants	6 Participants n=21 Participants
Type of Sarcoma Non-Uterine Leiomyosarcoma	4 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	10 Participants n=4 Participants	18 Participants n=21 Participants
Type of Sarcoma Dedifferentiated Liposarcoma	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	9 Participants n=21 Participants
Type of Sarcoma Myxoid/Round Cell Liposarcoma	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Type of Sarcoma Pleomorphic Liposarcoma	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Lines of Prior Therapy 0 Lines of Prior Therapy	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants	5 Participants n=21 Participants
Lines of Prior Therapy 1 Line of Prior Therapy	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	8 Participants n=4 Participants	12 Participants n=21 Participants
Lines of Prior Therapy 2 Lines of Prior Therapy	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	7 Participants n=21 Participants
Lines of Prior Therapy 3 Lines of Prior Therapy	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	5 Participants n=21 Participants
Lines of Prior Therapy 4 Lines of Prior Therapy	0 Participants n=5 Participants	4 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	4 Participants n=21 Participants
Lines of Prior Therapy 5 Lines of Prior Therapy	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants

PRIMARY outcome

Timeframe: up to 2 years 7 months total

Population: Cumulative number of adverse events experienced on trial by all patients, reported per grade.

Measured by Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0.

Outcome measures

Measure	Phase 1 - 1.5 mg/m^2 Trabectedin n=6 Participants Subjects received 1.5 mg/m2 of trabectedin plus avelumab.	Phase 1 - 1.0 mg/m^2 Trabectedin n=7 Participants Subjects received 1.0 mg/m\^2 trabectedin plus avelumab.	Phase 1 - 1.2 mg/m^2 Trabectedin n=6 Participants Subjects received 1.2 mg/m\^2 trabectedin plus avelumab.	Phase 2 - 1.0 mg/m^2 Trabectedin n=16 Participants Subjects received 1.0 mg/m\^2 trabectedin plus avelumab.
Incidence of Adverse Events Grade 1	95 number of adverse events	98 number of adverse events	86 number of adverse events	201 number of adverse events
Incidence of Adverse Events Grade 2	41 number of adverse events	46 number of adverse events	33 number of adverse events	115 number of adverse events
Incidence of Adverse Events Grade 3	12 number of adverse events	14 number of adverse events	9 number of adverse events	40 number of adverse events
Incidence of Adverse Events Grade 4	2 number of adverse events	0 number of adverse events	0 number of adverse events	6 number of adverse events
Incidence of Adverse Events Grade 5	1 number of adverse events	0 number of adverse events	0 number of adverse events	0 number of adverse events

PRIMARY outcome

Timeframe: Up to 2 years 7 months total

Population: Subjects enrolled in Phase 2 plus subjects treated at the Recommended Phase 2 Dose (RP2D).

Rate of Partial Response (PR) + Complete Response (CR), which is the best response for each subject determined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 for target lesions and assessed by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) scan. Partial response is defined as a decrease in 30% or more in the sum of the longest diameter of target lesions, and complete response is defined as disappearance of all evaluable disease. No subjects had a complete response on this study so the ORR represents subjects who had a partial response only.

Outcome measures

Measure	Phase 1 - 1.5 mg/m^2 Trabectedin n=23 Participants Subjects received 1.5 mg/m2 of trabectedin plus avelumab.	Phase 1 - 1.0 mg/m^2 Trabectedin Subjects received 1.0 mg/m\^2 trabectedin plus avelumab.	Phase 1 - 1.2 mg/m^2 Trabectedin Subjects received 1.2 mg/m\^2 trabectedin plus avelumab.	Phase 2 - 1.0 mg/m^2 Trabectedin Subjects received 1.0 mg/m\^2 trabectedin plus avelumab.
Overall Response Rate (ORR)	13 percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Up to 2 years 7 months total

Population: Average time to response for the 4 subjects who responded in both Phase 1 and Phase 2. Only subjects who had a response to treatment are included in this analysis.

Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Time to response is defined as the amount of time from when the subject first received study treatment (Cycle 1, Day 1) to when they achieved a partial response on trial.

With such small numbers, this data is not necessarily representative of what a larger study would report.

Outcome measures

Measure	Phase 1 - 1.5 mg/m^2 Trabectedin n=1 Participants Subjects received 1.5 mg/m2 of trabectedin plus avelumab.	Phase 1 - 1.0 mg/m^2 Trabectedin Subjects received 1.0 mg/m\^2 trabectedin plus avelumab.	Phase 1 - 1.2 mg/m^2 Trabectedin Subjects received 1.2 mg/m\^2 trabectedin plus avelumab.	Phase 2 - 1.0 mg/m^2 Trabectedin n=3 Participants Subjects received 1.0 mg/m\^2 trabectedin plus avelumab.
Time to Response	158 days	—	—	189 days Interval 77.0 to 329.0

SECONDARY outcome

Timeframe: Up to 2 years 7 months total

Population: Average duration of response for the 4 subjects who responded to treatment in both Phase 1 and Phase 2. Only subjects who had a response to treatment are included in this analysis.

Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Duration of response is defined as the amount of time a subject responded to study treatment with either a partial response or complete response until the date of last follow-up (if response ongoing at data cutoff) or the date until they progressed on study.

Outcome measures

Measure	Phase 1 - 1.5 mg/m^2 Trabectedin n=1 Participants Subjects received 1.5 mg/m2 of trabectedin plus avelumab.	Phase 1 - 1.0 mg/m^2 Trabectedin Subjects received 1.0 mg/m\^2 trabectedin plus avelumab.	Phase 1 - 1.2 mg/m^2 Trabectedin Subjects received 1.2 mg/m\^2 trabectedin plus avelumab.	Phase 2 - 1.0 mg/m^2 Trabectedin n=3 Participants Subjects received 1.0 mg/m\^2 trabectedin plus avelumab.
Duration of Response	NA days Data not representative of actual duration of response due to low response rate overall, late time to response for 1 subject, and study closing early while subjects still responding.	—	—	NA days Data not representative of actual duration of response due to low response rate overall, late time to response for 1 subject, and study closing early while subjects still responding.

SECONDARY outcome

Timeframe: At 12 weeks

Population: All subjects treated in Phase 1 and Phase 2 evaluated at 3 months. NOTE: one subject was not evaluable for response and was replaced after withdrawing from study before response evaluation.

Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Progression is defined using RECIST v1.1, as a 20% increase in the sum of the longest diameter of target lesions, appearance of new lesions while on study, or clear growth of a non-target lesion.

Outcome measures

Measure	Phase 1 - 1.5 mg/m^2 Trabectedin n=6 Participants Subjects received 1.5 mg/m2 of trabectedin plus avelumab.	Phase 1 - 1.0 mg/m^2 Trabectedin n=6 Participants Subjects received 1.0 mg/m\^2 trabectedin plus avelumab.	Phase 1 - 1.2 mg/m^2 Trabectedin n=6 Participants Subjects received 1.2 mg/m\^2 trabectedin plus avelumab.	Phase 2 - 1.0 mg/m^2 Trabectedin n=16 Participants Subjects received 1.0 mg/m\^2 trabectedin plus avelumab.
Progression-free Survival (PFS)	50 percentage of participants	50 percentage of participants	83 percentage of participants	63 percentage of participants

SECONDARY outcome

Timeframe: At 12 weeks

Population: NOTE: one subject was not evaluable for response and was replaced after withdrawing from study before response evaluation.

Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Complete Response is defined as disappearance of all evaluable disease.

Outcome measures

Measure	Phase 1 - 1.5 mg/m^2 Trabectedin n=6 Participants Subjects received 1.5 mg/m2 of trabectedin plus avelumab.	Phase 1 - 1.0 mg/m^2 Trabectedin n=6 Participants Subjects received 1.0 mg/m\^2 trabectedin plus avelumab.	Phase 1 - 1.2 mg/m^2 Trabectedin n=6 Participants Subjects received 1.2 mg/m\^2 trabectedin plus avelumab.	Phase 2 - 1.0 mg/m^2 Trabectedin n=16 Participants Subjects received 1.0 mg/m\^2 trabectedin plus avelumab.
Complete Response Rate (CR)	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: At 12 weeks

Population: NOTE: One subject was not evaluable for response and was replaced after withdrawing from the study before response evaluation.

Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Partial response is defined as a decrease in 30% or more in the sum of the longest diameter of target lesions.

Outcome measures

Measure	Phase 1 - 1.5 mg/m^2 Trabectedin n=6 Participants Subjects received 1.5 mg/m2 of trabectedin plus avelumab.	Phase 1 - 1.0 mg/m^2 Trabectedin n=6 Participants Subjects received 1.0 mg/m\^2 trabectedin plus avelumab.	Phase 1 - 1.2 mg/m^2 Trabectedin n=6 Participants Subjects received 1.2 mg/m\^2 trabectedin plus avelumab.	Phase 2 - 1.0 mg/m^2 Trabectedin n=16 Participants Subjects received 1.0 mg/m\^2 trabectedin plus avelumab.
Partial Response Rate (PR)	1 Participants	0 Participants	0 Participants	3 Participants

SECONDARY outcome

Timeframe: At 12 weeks

Population: NOTE: one subject was not evaluable for response and was replaced after withdrawing from the study before response evaluation.

Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Stable Disease is defined as neither sufficient shrinkage to qualify for a Partial Response (PR) nor sufficient increase to qualify for Progressive Disease (PD).

Outcome measures

Measure	Phase 1 - 1.5 mg/m^2 Trabectedin n=6 Participants Subjects received 1.5 mg/m2 of trabectedin plus avelumab.	Phase 1 - 1.0 mg/m^2 Trabectedin n=6 Participants Subjects received 1.0 mg/m\^2 trabectedin plus avelumab.	Phase 1 - 1.2 mg/m^2 Trabectedin n=6 Participants Subjects received 1.2 mg/m\^2 trabectedin plus avelumab.	Phase 2 - 1.0 mg/m^2 Trabectedin n=16 Participants Subjects received 1.0 mg/m\^2 trabectedin plus avelumab.
Stable Disease (SD)	2 Participants	3 Participants	4 Participants	7 Participants

SECONDARY outcome

Timeframe: At 12 weeks

Population: Subjects with a Partial Response (PR) or Stable Disease (SD) treated at the RP2D. No subjects achieved a Complete Response (CR) while on study.

Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Clinical Benefit Rate is defined as the percentage of subjects who achieved a Complete Response (CR) + Partial Response (PR) + Stable Disease (SD).

Outcome measures

Measure	Phase 1 - 1.5 mg/m^2 Trabectedin n=23 Participants Subjects received 1.5 mg/m2 of trabectedin plus avelumab.	Phase 1 - 1.0 mg/m^2 Trabectedin Subjects received 1.0 mg/m\^2 trabectedin plus avelumab.	Phase 1 - 1.2 mg/m^2 Trabectedin Subjects received 1.2 mg/m\^2 trabectedin plus avelumab.	Phase 2 - 1.0 mg/m^2 Trabectedin Subjects received 1.0 mg/m\^2 trabectedin plus avelumab.
Clinical Benefit Rate	56 percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Up to 2 years post End of Treatment, for a total of 3 years

Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

Outcome measures

Measure	Phase 1 - 1.5 mg/m^2 Trabectedin n=6 Participants Subjects received 1.5 mg/m2 of trabectedin plus avelumab.	Phase 1 - 1.0 mg/m^2 Trabectedin n=7 Participants Subjects received 1.0 mg/m\^2 trabectedin plus avelumab.	Phase 1 - 1.2 mg/m^2 Trabectedin n=6 Participants Subjects received 1.2 mg/m\^2 trabectedin plus avelumab.	Phase 2 - 1.0 mg/m^2 Trabectedin n=16 Participants Subjects received 1.0 mg/m\^2 trabectedin plus avelumab.
Median Overall Survival (OS)	391 days Interval 22.0 to 759.0	416 days Interval 0.0 to 906.0	NA days The study was closed early when Principal Investigator left institution, so outcome was not reached for this cohort.	NA days The study was closed early when Principal Investigator left institution, so outcome was not reached for this cohort.

SECONDARY outcome

Timeframe: Up to 2 years 7 months total

Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0

Outcome measures

Measure	Phase 1 - 1.5 mg/m^2 Trabectedin n=6 Participants Subjects received 1.5 mg/m2 of trabectedin plus avelumab.	Phase 1 - 1.0 mg/m^2 Trabectedin n=7 Participants Subjects received 1.0 mg/m\^2 trabectedin plus avelumab.	Phase 1 - 1.2 mg/m^2 Trabectedin n=6 Participants Subjects received 1.2 mg/m\^2 trabectedin plus avelumab.	Phase 2 - 1.0 mg/m^2 Trabectedin n=16 Participants Subjects received 1.0 mg/m\^2 trabectedin plus avelumab.
Adverse Event Profile - All Treatment-Related Grade 3-5 Adverse Events Alanine Aminotransferase Increased	1 Events	1 Events	1 Events	3 Events
Adverse Event Profile - All Treatment-Related Grade 3-5 Adverse Events Lymphocyte Count Decreased	0 Events	0 Events	0 Events	4 Events
Adverse Event Profile - All Treatment-Related Grade 3-5 Adverse Events Neutrophil Count Decreased	1 Events	2 Events	0 Events	0 Events
Adverse Event Profile - All Treatment-Related Grade 3-5 Adverse Events Anemia	0 Events	0 Events	0 Events	2 Events
Adverse Event Profile - All Treatment-Related Grade 3-5 Adverse Events Ejection Fraction Decreased	1 Events	0 Events	1 Events	0 Events
Adverse Event Profile - All Treatment-Related Grade 3-5 Adverse Events Aspartate Aminotransferase Increased	0 Events	0 Events	0 Events	1 Events
Adverse Event Profile - All Treatment-Related Grade 3-5 Adverse Events Blood Bilirubin Increased	1 Events	0 Events	0 Events	0 Events
Adverse Event Profile - All Treatment-Related Grade 3-5 Adverse Events Dyspnea	0 Events	0 Events	0 Events	1 Events
Adverse Event Profile - All Treatment-Related Grade 3-5 Adverse Events Fatigue	0 Events	0 Events	0 Events	1 Events
Adverse Event Profile - All Treatment-Related Grade 3-5 Adverse Events Gastrointestinal Disorders - Other	0 Events	1 Events	0 Events	0 Events
Adverse Event Profile - All Treatment-Related Grade 3-5 Adverse Events GGT Increased	1 Events	0 Events	0 Events	0 Events
Adverse Event Profile - All Treatment-Related Grade 3-5 Adverse Events Hepatobiliary Disorders - Other	1 Events	0 Events	0 Events	0 Events
Adverse Event Profile - All Treatment-Related Grade 3-5 Adverse Events Hypophosphatemia	1 Events	0 Events	0 Events	0 Events
Adverse Event Profile - All Treatment-Related Grade 3-5 Adverse Events Infections and Infestations - Other (Port Infection/Inflammation/Erythema)	1 Events	0 Events	0 Events	0 Events
Adverse Event Profile - All Treatment-Related Grade 3-5 Adverse Events Infusion Related Reaction	0 Events	0 Events	0 Events	1 Events
Adverse Event Profile - All Treatment-Related Grade 3-5 Adverse Events Muscle Weakness Lower Limb	0 Events	0 Events	0 Events	1 Events
Adverse Event Profile - All Treatment-Related Grade 3-5 Adverse Events Respiratory Failure	1 Events	0 Events	0 Events	0 Events
Adverse Event Profile - All Treatment-Related Grade 3-5 Adverse Events Syncope	1 Events	0 Events	0 Events	0 Events
Adverse Event Profile - All Treatment-Related Grade 3-5 Adverse Events White Blood Cell Decreased	1 Events	0 Events	0 Events	0 Events

Adverse Events

Phase 1 - 1.5 mg/m^2 Trabectedin

Serious events: 2 serious events

Other events: 6 other events

Deaths: 4 deaths

Phase 1 - 1.0 mg/m^2 Trabectedin

Serious events: 2 serious events

Other events: 7 other events

Deaths: 5 deaths

Phase 1 - 1.2mg/m^2 Trabectedin

Serious events: 1 serious events

Other events: 6 other events

Deaths: 2 deaths

Phase 2 - 1.0 mg/m^2 Trabectedin

Serious events: 7 serious events

Other events: 16 other events

Deaths: 1 deaths

Serious adverse events

Measure	Phase 1 - 1.5 mg/m^2 Trabectedin n=6 participants at risk Avelumab will be administered every 2 weeks. Trabectedin will be administered every 3 weeks for the first two doses (Week 1 and Week 4), and then every four weeks (Week 7, Week 11,…) moving forward. After Cycle 2 of trabectedin, dosing may extend to every 5 weeks at investigator discretion, for management of trabectedin-associated toxicity only. Delays of trabectedin beyond 5 weeks may be allowed but require written approval from the Sponsor-Investigator. On days where both drugs are scheduled to be administered, avelumab will be administered first. This will continue until unacceptable toxicity or confirmed disease progression. Avelumab: Given IV Trabectedin: Given IV	Phase 1 - 1.0 mg/m^2 Trabectedin n=7 participants at risk Avelumab will be administered every 2 weeks. Trabectedin will be administered every 3 weeks for the first two doses (Week 1 and Week 4), and then every four weeks (Week 7, Week 11,…) moving forward. After Cycle 2 of trabectedin, dosing may extend to every 5 weeks at investigator discretion, for management of trabectedin-associated toxicity only. Delays of trabectedin beyond 5 weeks may be allowed but require written approval from the Sponsor-Investigator. On days where both drugs are scheduled to be administered, avelumab will be administered first. This will continue until unacceptable toxicity or confirmed disease progression.	Phase 1 - 1.2mg/m^2 Trabectedin n=6 participants at risk Avelumab will be administered every 2 weeks. Trabectedin will be administered every 3 weeks for the first two doses (Week 1 and Week 4), and then every four weeks (Week 7, Week 11,…) moving forward. After Cycle 2 of trabectedin, dosing may extend to every 5 weeks at investigator discretion, for management of trabectedin-associated toxicity only. Delays of trabectedin beyond 5 weeks may be allowed but require written approval from the Sponsor-Investigator. On days where both drugs are scheduled to be administered, avelumab will be administered first. This will continue until unacceptable toxicity or confirmed disease progression.	Phase 2 - 1.0 mg/m^2 Trabectedin n=16 participants at risk Avelumab will be administered every 2 weeks. Trabectedin will be administered every 3 weeks for the first two doses (Week 1 and Week 4), and then every four weeks (Week 7, Week 11,…) moving forward. After Cycle 2 of trabectedin, dosing may extend to every 5 weeks at investigator discretion, for management of trabectedin-associated toxicity only. Delays of trabectedin beyond 5 weeks may be allowed but require written approval from the Sponsor-Investigator. On days where both drugs are scheduled to be administered, avelumab will be administered first. This will continue until unacceptable toxicity or confirmed disease progression. Avelumab: Given IV Trabectedin: Given IV
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor Pain	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	6.2% 1/16 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Hepatobiliary disorders LFT Elevation	16.7% 1/6 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/16 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Renal and urinary disorders Acute kidney injury	16.7% 1/6 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/16 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Respiratory, thoracic and mediastinal disorders Respiratory failure	16.7% 1/6 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/16 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	12.5% 2/16 • Number of events 2 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Cardiac disorders Tricuspid valve disease	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	6.2% 1/16 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
General disorders Fever	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	6.2% 1/16 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Gastrointestinal disorders Gastrointestinal disorders - other	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	14.3% 1/7 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/16 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Gastrointestinal disorders Abdominal Pain	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	16.7% 1/6 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/16 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Gastrointestinal disorders Rectal hemorrhage	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	6.2% 1/16 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Gastrointestinal disorders Upper gastrointestinal hemorrhage	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	6.2% 1/16 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Nervous system disorders Seizure	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	6.2% 1/16 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Vascular disorders Hypotension	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	6.2% 1/16 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	6.2% 1/16 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Infections and infestations Enterocolitis infectious	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	6.2% 1/16 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Infections and infestations Urinary tract infection	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	6.2% 1/16 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Infections and infestations Biliary tract infection	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	6.2% 1/16 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tricuspid valve mass	16.7% 1/6 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/16 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	6.2% 1/16 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	6.2% 1/16 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	6.2% 1/16 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Vascular disorders Pulmonary Embolism	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	6.2% 1/16 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Nervous system disorders Syncope	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	14.3% 1/7 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/16 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.

Other adverse events

Measure	Phase 1 - 1.5 mg/m^2 Trabectedin n=6 participants at risk Avelumab will be administered every 2 weeks. Trabectedin will be administered every 3 weeks for the first two doses (Week 1 and Week 4), and then every four weeks (Week 7, Week 11,…) moving forward. After Cycle 2 of trabectedin, dosing may extend to every 5 weeks at investigator discretion, for management of trabectedin-associated toxicity only. Delays of trabectedin beyond 5 weeks may be allowed but require written approval from the Sponsor-Investigator. On days where both drugs are scheduled to be administered, avelumab will be administered first. This will continue until unacceptable toxicity or confirmed disease progression. Avelumab: Given IV Trabectedin: Given IV	Phase 1 - 1.0 mg/m^2 Trabectedin n=7 participants at risk Avelumab will be administered every 2 weeks. Trabectedin will be administered every 3 weeks for the first two doses (Week 1 and Week 4), and then every four weeks (Week 7, Week 11,…) moving forward. After Cycle 2 of trabectedin, dosing may extend to every 5 weeks at investigator discretion, for management of trabectedin-associated toxicity only. Delays of trabectedin beyond 5 weeks may be allowed but require written approval from the Sponsor-Investigator. On days where both drugs are scheduled to be administered, avelumab will be administered first. This will continue until unacceptable toxicity or confirmed disease progression.	Phase 1 - 1.2mg/m^2 Trabectedin n=6 participants at risk Avelumab will be administered every 2 weeks. Trabectedin will be administered every 3 weeks for the first two doses (Week 1 and Week 4), and then every four weeks (Week 7, Week 11,…) moving forward. After Cycle 2 of trabectedin, dosing may extend to every 5 weeks at investigator discretion, for management of trabectedin-associated toxicity only. Delays of trabectedin beyond 5 weeks may be allowed but require written approval from the Sponsor-Investigator. On days where both drugs are scheduled to be administered, avelumab will be administered first. This will continue until unacceptable toxicity or confirmed disease progression.	Phase 2 - 1.0 mg/m^2 Trabectedin n=16 participants at risk Avelumab will be administered every 2 weeks. Trabectedin will be administered every 3 weeks for the first two doses (Week 1 and Week 4), and then every four weeks (Week 7, Week 11,…) moving forward. After Cycle 2 of trabectedin, dosing may extend to every 5 weeks at investigator discretion, for management of trabectedin-associated toxicity only. Delays of trabectedin beyond 5 weeks may be allowed but require written approval from the Sponsor-Investigator. On days where both drugs are scheduled to be administered, avelumab will be administered first. This will continue until unacceptable toxicity or confirmed disease progression. Avelumab: Given IV Trabectedin: Given IV
Eye disorders Blurred Vision	16.7% 1/6 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	16.7% 1/6 • Number of events 2 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	12.5% 2/16 • Number of events 2 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Investigations Alkaline Phosphatase Increased	16.7% 1/6 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	16.7% 1/6 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	12.5% 2/16 • Number of events 9 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Investigations Weight loss	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	16.7% 1/6 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	18.8% 3/16 • Number of events 4 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
General disorders Non-cardiac chest pain	16.7% 1/6 • Number of events 2 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	28.6% 2/7 • Number of events 3 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	6.2% 1/16 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Nervous system disorders Nervous System Disorders - Other	33.3% 2/6 • Number of events 3 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	16.7% 1/6 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	6.2% 1/16 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
General disorders Fatigue	100.0% 6/6 • Number of events 8 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	85.7% 6/7 • Number of events 6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	83.3% 5/6 • Number of events 6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	100.0% 16/16 • Number of events 19 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Gastrointestinal disorders Nausea	100.0% 6/6 • Number of events 8 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	71.4% 5/7 • Number of events 5 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	50.0% 3/6 • Number of events 3 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	81.2% 13/16 • Number of events 14 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Gastrointestinal disorders Diarrhea	83.3% 5/6 • Number of events 5 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	57.1% 4/7 • Number of events 10 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	66.7% 4/6 • Number of events 6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	37.5% 6/16 • Number of events 7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Metabolism and nutrition disorders Anorexia	50.0% 3/6 • Number of events 3 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	57.1% 4/7 • Number of events 4 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	83.3% 5/6 • Number of events 6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	50.0% 8/16 • Number of events 8 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Gastrointestinal disorders Vomiting	83.3% 5/6 • Number of events 7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	28.6% 2/7 • Number of events 4 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	50.0% 3/6 • Number of events 4 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	50.0% 8/16 • Number of events 9 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Investigations Alanine aminotransferase increase	50.0% 3/6 • Number of events 5 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	14.3% 1/7 • Number of events 2 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	83.3% 5/6 • Number of events 7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	37.5% 6/16 • Number of events 19 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Gastrointestinal disorders Constipation	16.7% 1/6 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	42.9% 3/7 • Number of events 3 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	66.7% 4/6 • Number of events 6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	31.2% 5/16 • Number of events 5 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Musculoskeletal and connective tissue disorders Bone Pain	33.3% 2/6 • Number of events 2 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	42.9% 3/7 • Number of events 3 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	33.3% 2/6 • Number of events 2 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	37.5% 6/16 • Number of events 6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Musculoskeletal and connective tissue disorders Myalgia	33.3% 2/6 • Number of events 2 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	14.3% 1/7 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	50.0% 3/6 • Number of events 5 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	31.2% 5/16 • Number of events 5 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Nervous system disorders Headache	33.3% 2/6 • Number of events 2 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	28.6% 2/7 • Number of events 3 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	50.0% 3/6 • Number of events 3 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	25.0% 4/16 • Number of events 7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
General disorders Pain	66.7% 4/6 • Number of events 6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	28.6% 2/7 • Number of events 4 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	25.0% 4/16 • Number of events 4 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Nervous system disorders Dysgeusia	50.0% 3/6 • Number of events 3 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	28.6% 2/7 • Number of events 2 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	33.3% 2/6 • Number of events 2 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	25.0% 4/16 • Number of events 4 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Injury, poisoning and procedural complications Infusion related reaction	33.3% 2/6 • Number of events 2 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	28.6% 2/7 • Number of events 2 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	33.3% 2/6 • Number of events 2 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	50.0% 8/16 • Number of events 12 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Respiratory, thoracic and mediastinal disorders Dyspnea	66.7% 4/6 • Number of events 4 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	33.3% 2/6 • Number of events 3 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	31.2% 5/16 • Number of events 10 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Investigations Aspartate aminotransferase increased	50.0% 3/6 • Number of events 4 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	16.7% 1/6 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	31.2% 5/16 • Number of events 9 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Nervous system disorders Dizziness	50.0% 3/6 • Number of events 3 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	14.3% 1/7 • Number of events 2 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	33.3% 2/6 • Number of events 3 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	12.5% 2/16 • Number of events 2 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Psychiatric disorders Insomnia	33.3% 2/6 • Number of events 2 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	28.6% 2/7 • Number of events 2 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	33.3% 2/6 • Number of events 2 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	12.5% 2/16 • Number of events 2 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Blood and lymphatic system disorders Anemia	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	14.3% 1/7 • Number of events 2 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	16.7% 1/6 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	37.5% 6/16 • Number of events 11 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
General disorders Flu like symptoms	16.7% 1/6 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	42.9% 3/7 • Number of events 6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	6.2% 1/16 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Investigations Lymphocyte count decreased	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	14.3% 1/7 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	68.8% 11/16 • Number of events 20 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	14.3% 1/7 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	33.3% 2/6 • Number of events 3 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	25.0% 4/16 • Number of events 5 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	14.3% 1/7 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	33.3% 2/6 • Number of events 4 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	25.0% 4/16 • Number of events 4 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Investigations Creatinine Increaed	33.3% 2/6 • Number of events 3 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	14.3% 1/7 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	18.8% 3/16 • Number of events 5 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
General disorders Fever	33.3% 2/6 • Number of events 3 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	28.6% 2/7 • Number of events 3 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	18.8% 3/16 • Number of events 8 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Gastrointestinal disorders Abdominal Pain	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	28.6% 2/7 • Number of events 2 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	33.3% 2/6 • Number of events 3 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	18.8% 3/16 • Number of events 4 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	50.0% 3/6 • Number of events 3 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	16.7% 1/6 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	12.5% 2/16 • Number of events 3 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
General disorders Chills	16.7% 1/6 • Number of events 2 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	28.6% 2/7 • Number of events 3 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	16.7% 1/6 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	6.2% 1/16 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Gastrointestinal disorders Gastroesophageal reflux disease	16.7% 1/6 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	28.6% 2/7 • Number of events 2 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	16.7% 1/6 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	6.2% 1/16 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Infections and infestations Upper Respiratory Infection	33.3% 2/6 • Number of events 2 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	14.3% 1/7 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	16.7% 1/6 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	6.2% 1/16 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Infections and infestations Dry Skin	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	28.6% 2/7 • Number of events 2 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	18.8% 3/16 • Number of events 3 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Cardiac disorders Palpitations	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	16.7% 1/6 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	18.8% 3/16 • Number of events 3 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Nervous system disorders Tremor	16.7% 1/6 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	18.8% 3/16 • Number of events 3 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	14.3% 1/7 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	16.7% 1/6 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	12.5% 2/16 • Number of events 3 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Vascular disorders Hot flashes	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	14.3% 1/7 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	18.8% 3/16 • Number of events 3 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Infections and infestations Infections and infestations - Other	50.0% 3/6 • Number of events 3 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	42.9% 3/7 • Number of events 3 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	50.0% 3/6 • Number of events 3 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	25.0% 4/16 • Number of events 5 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Endocrine disorders Hypothyroidism	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	14.3% 1/7 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	18.8% 3/16 • Number of events 4 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Skin and subcutaneous tissue disorders Hyperhidrosis	33.3% 2/6 • Number of events 2 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	14.3% 1/7 • Number of events 2 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	16.7% 1/6 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/16 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Skin and subcutaneous tissue disorders Rash acneiform	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	14.3% 1/7 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	18.8% 3/16 • Number of events 3 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Investigations Neutrophil count decreased	16.7% 1/6 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	42.9% 3/7 • Number of events 9 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	6.2% 1/16 • Number of events 2 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Investigations Platelet count decreased	33.3% 2/6 • Number of events 2 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	16.7% 1/6 • Number of events 6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	12.5% 2/16 • Number of events 4 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
General disorders Edema limbs	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	28.6% 2/7 • Number of events 2 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	16.7% 1/6 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	12.5% 2/16 • Number of events 3 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Gastrointestinal disorders Dry Mouth	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	28.6% 2/7 • Number of events 2 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	6.2% 1/16 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Gastrointestinal disorders Oral pain	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	14.3% 1/7 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	12.5% 2/16 • Number of events 2 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Injury, poisoning and procedural complications Bruising	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	18.8% 3/16 • Number of events 3 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Nervous system disorders Paresthesia	16.7% 1/6 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	14.3% 1/7 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	16.7% 1/6 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/16 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Musculoskeletal and connective tissue disorders Arthralgia	16.7% 1/6 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	16.7% 1/6 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	6.2% 1/16 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Vascular disorders Hypotension	33.3% 2/6 • Number of events 2 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	16.7% 1/6 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	6.2% 1/16 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Vascular disorders Thromboembolic event	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	28.6% 2/7 • Number of events 2 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	6.2% 1/16 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Metabolism and nutrition disorders Hypokalemia	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	14.3% 1/7 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	12.5% 2/16 • Number of events 2 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Metabolism and nutrition disorders Hypocalcemia	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	16.7% 1/6 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	25.0% 4/16 • Number of events 4 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor Pain	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	28.6% 2/7 • Number of events 2 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	16.7% 1/6 • Number of events 2 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	6.2% 1/16 • Number of events 3 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Renal and urinary disorders Urinary frequency	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	14.3% 1/7 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	16.7% 1/6 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	6.2% 1/16 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Cardiac disorders Sinus tachycardia	16.7% 1/6 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	6.2% 1/16 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Eye disorders Dry eye	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	16.7% 1/6 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	6.2% 1/16 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Eye disorders Floaters	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	12.5% 2/16 • Number of events 2 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Investigations White blood cell decreased	16.7% 1/6 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	16.7% 1/6 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	12.5% 2/16 • Number of events 4 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Gastrointestinal disorders Flatulence	16.7% 1/6 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	16.7% 1/6 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/16 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Gastrointestinal disorders Stomach Pain	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	33.3% 2/6 • Number of events 2 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/16 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Gastrointestinal disorders Mucositis oral	16.7% 1/6 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	14.3% 1/7 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	6.2% 1/16 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Injury, poisoning and procedural complications Wound complication	16.7% 1/6 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	6.2% 1/16 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Nervous system disorders Syncope	16.7% 1/6 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	16.7% 1/6 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/16 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Nervous system disorders Extrapyramidal disorder	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	16.7% 1/6 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	6.2% 1/16 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Nervous system disorders Cognitive disturbance	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	14.3% 1/7 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	16.7% 1/6 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/16 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Musculoskeletal and connective tissue disorders Neck Pain	16.7% 1/6 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	14.3% 1/7 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/16 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Musculoskeletal and connective tissue disorders Back Pain	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	14.3% 1/7 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	6.2% 1/16 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Musculoskeletal and connective tissue disorders Muscle Cramp	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	12.5% 2/16 • Number of events 2 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Psychiatric disorders Anxiety	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	14.3% 1/7 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	6.2% 1/16 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Psychiatric disorders Depression	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	16.7% 1/6 • Number of events 2 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	6.2% 1/16 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Vascular disorders Hematoma	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	16.7% 1/6 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	6.2% 1/16 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Blood and lymphatic system disorders Leukocytosis	33.3% 2/6 • Number of events 2 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/16 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Metabolism and nutrition disorders Dehydration	16.7% 1/6 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	16.7% 1/6 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/16 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Metabolism and nutrition disorders Hypoalbuminemia	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	12.5% 2/16 • Number of events 2 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other	50.0% 3/6 • Number of events 3 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	42.9% 3/7 • Number of events 3 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	6.2% 1/16 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Skin and subcutaneous tissue disorders Pain of skin	16.7% 1/6 • Number of events 2 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/16 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	28.6% 2/7 • Number of events 2 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	6.2% 1/16 • Number of events 3 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Respiratory, thoracic and mediastinal disorders Postnasal drip	16.7% 1/6 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	14.3% 1/7 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/16 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Respiratory, thoracic and mediastinal disorders Hoarseness	16.7% 1/6 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	6.2% 1/16 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Respiratory, thoracic and mediastinal disorders Sore throat	16.7% 1/6 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	14.3% 1/7 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/16 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Respiratory, thoracic and mediastinal disorders Rhinorrhea	16.7% 1/6 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	6.2% 1/16 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	14.3% 1/7 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	6.2% 1/16 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	12.5% 2/16 • Number of events 2 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Investigations Ejection fraction decreased	16.7% 1/6 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	33.3% 2/6 • Number of events 3 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/16 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Infections and infestations Sinusitis	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	14.3% 1/7 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	16.7% 1/6 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/16 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Infections and infestations Skin Infection	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	16.7% 1/6 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	6.2% 1/16 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Gastrointestinal disorders Rectal hemorrhage	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	6.2% 1/16 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	6.2% 1/16 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Cardiac disorders Chest Pain - Cardiac	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	6.2% 1/16 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Cardiac disorders Ventricular arrhythmia	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	6.2% 1/16 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Cardiac disorders Tricuspid Valve Disease	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	6.2% 1/16 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Eye disorders Watering Eyes	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	6.2% 1/16 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Investigations CPK increased	16.7% 1/6 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	14.3% 1/7 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	6.2% 1/16 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Investigations Cardiac troponin I increased	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	6.2% 1/16 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Investigations INR Increased	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	6.2% 1/16 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Gastrointestinal disorders Active Diverticulitis	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	6.2% 1/16 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Gastrointestinal disorders Dyspepsia	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	6.2% 1/16 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Nervous system disorders Presyncope	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	6.2% 1/16 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Nervous system disorders Radiculitis	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	6.2% 1/16 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Nervous system disorders Lethargy	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	6.2% 1/16 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	6.2% 1/16 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Musculoskeletal and connective tissue disorders Left Total Hip Dislocation	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	6.2% 1/16 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Nervous system disorders Hallucinations	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	6.2% 1/16 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Nervous system disorders Confusion	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	6.2% 1/16 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Infections and infestations Enterocolitis infectious	16.7% 1/6 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/16 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Immune system disorders Urinary Tract Infection	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	6.2% 1/16 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Infections and infestations Lip Infection	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	6.2% 1/16 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Infections and infestations Biliary tract infection	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	6.2% 1/16 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Renal and urinary disorders Renal and urinary disorders - Other	16.7% 1/6 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	14.3% 1/7 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	6.2% 1/16 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Renal and urinary disorders Urinary tract obstruction	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	6.2% 1/16 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Endocrine disorders Hyperparathyroidism	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	6.2% 1/16 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Ear and labyrinth disorders Tinnitus	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	6.2% 1/16 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Skin and subcutaneous tissue disorders Skin Hyperpigmentation	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	6.2% 1/16 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	6.2% 1/16 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Skin and subcutaneous tissue disorders Skin Hypopigmentation	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	6.2% 1/16 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Skin and subcutaneous tissue disorders Erythema multiforme	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	6.2% 1/16 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	16.7% 1/6 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	6.2% 1/16 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	6.2% 1/16 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Respiratory, thoracic and mediastinal disorders Pulmonary edema	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	6.2% 1/16 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	6.2% 1/16 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	6.2% 1/16 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Eye disorders Eye Disorders - Other	16.7% 1/6 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	16.7% 1/6 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/16 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Investigations Blood bilirubin increased	16.7% 1/6 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/16 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Investigations GGT increased	16.7% 1/6 • Number of events 2 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/16 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Investigations Investigations - Other	33.3% 2/6 • Number of events 2 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	6.2% 1/16 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
General disorders Soreness	16.7% 1/6 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/16 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
General disorders Localized edema	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	14.3% 1/7 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/16 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
General disorders Pyrosis	16.7% 1/6 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/16 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Gastrointestinal disorders Gastrointestinal disorders - other	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	14.3% 1/7 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/16 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Gastrointestinal disorders Ascites	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	14.3% 1/7 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/16 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Gastrointestinal disorders Toothache	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	14.3% 1/7 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/16 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Gastrointestinal disorders Colitis	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	16.7% 1/6 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/16 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Gastrointestinal disorders Colonic obstruction	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	16.7% 1/6 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/16 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Injury, poisoning and procedural complications Fracture	16.7% 1/6 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/16 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Nervous system disorders Concentration impairment	33.3% 2/6 • Number of events 2 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/16 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Nervous system disorders Neuralgia	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	16.7% 1/6 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/16 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
General disorders Body Aches	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	14.3% 1/7 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/16 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorders - other	33.3% 2/6 • Number of events 2 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	57.1% 4/7 • Number of events 4 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/16 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Musculoskeletal and connective tissue disorders Chest Wall Pain	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	16.7% 1/6 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/16 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Psychiatric disorders Psychiatric disorders - Other	16.7% 1/6 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	14.3% 1/7 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/16 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Vascular disorders Vascular disorders - other	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	14.3% 1/7 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	6.2% 1/16 • Number of events 2 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Vascular disorders Flushing	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	14.3% 1/7 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/16 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Infections and infestations Infective myositis	16.7% 1/6 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/16 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Infections and infestations Urinary tract infection	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	14.3% 1/7 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/16 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Investigations Hypophosphatemia	16.7% 1/6 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/16 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Investigations Hypoglycemia	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	16.7% 1/6 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/16 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Investigations Hyponatremia	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	16.7% 1/6 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/16 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Sebaceous Cyst	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	16.7% 1/6 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/16 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Renal and urinary disorders Acute Kidney Injury	16.7% 1/6 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/16 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Renal and urinary disorders Hematuria	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	14.3% 1/7 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/16 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Reproductive system and breast disorders Irregular menstruation	16.7% 1/6 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/16 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Reproductive system and breast disorders Pelvic Pain	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	14.3% 1/7 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/16 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Endocrine disorders Endocrine Disorders - Other	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	14.3% 1/7 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/16 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Surgical and medical procedures Surgical and Medical Procedures - Other	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	33.3% 2/6 • Number of events 2 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	6.2% 1/16 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Skin and subcutaneous tissue disorders Photosensitivity	16.7% 1/6 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/16 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Skin and subcutaneous tissue disorders Burn	16.7% 1/6 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/16 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Skin and subcutaneous tissue disorders Scalp Pain	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	16.7% 1/6 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/16 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Respiratory, thoracic and mediastinal disorders Respiratory failure	16.7% 1/6 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/16 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	16.7% 1/6 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/16 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
Cardiac disorders Cardiac Disorders - Other	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/7 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	0.00% 0/6 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.	6.2% 1/16 • Number of events 1 • Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.

Additional Information

Seth Pollack, MD, Director of Sarcoma Program

Northwestern University

Phone: 312-503-5320

Email: seth.pollack@northwestern.edu

Results disclosure agreements

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