Trial Outcomes & Findings for Vaccine Therapy With or Without Cyclophosphamide in Treating Patients With Recurrent or Refractory Multiple Myeloma (NCT NCT00450814)

Last Updated: 2019-12-16

Results Overview

The Maximum Tolerated Dose (MTD) is defined as the dose level below the lowest dose that induces dose-limiting toxicity (DLT) in at least one-third of patients graded according to NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Dose-limiting toxicities include non-hematologic events graded 3 or higher and deemed at least possibly related to treatment. A total of 6 patients treated at the MTD will be sufficient to identify common toxicities at the MTD. The number of patients reporting a dose-limiting event are reported.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

48 participants

Primary outcome timeframe

6 weeks

Results posted on

2019-12-16

Participant Flow

Phase I: INITIALLY CLOSED ON 12/17/2009 AND STAGE 2 BEGUN; HOWEVER, DUE TO NEW MANUFACTURING CAPABILITIES, STAGE 1 RE-OPENED ON October 13, 2011, FOR DOSE LEVELS 5 AND 6. Phase II: Accrual to Cohort A closed due to failed interim analysis. Cohort B closed due to lack of accrual.

Participant milestones

Participant milestones
Measure	Phase I: Stage 1 (MV-NIS Alone) Dose Level 1 Patients receive 1x10\^6 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 1 (MV-NIS Alone) Dose Level 2 Patients receive 1x10\^7 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 1 (MV-NIS Alone) Dose Level 3 Patients receive 1x10\^8 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 1 (MV-NIS Alone) Dose Level 4 Patients receive 1x10\^9 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 1 (MV-NIS Alone) Dose Level 5 Patients receive 1x10\^10 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 1 (MV-NIS Alone) Dose Level 6 Patients receive 1x10\^11 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 1 Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then (Stage 1 MTD/100=10\^7) MV-NIS (TCID50) IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)	Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 2 Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then 3 x 10\^7 MV-NIS (TCID50) IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)	Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 3 Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then 9 x 10\^7 MV-NIS (TCID50) IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)	Phase II (Acetaminophen + Benadryl + MV-NIS) Cohort A Cohort A patients (relapsed or refractory multiple myeloma who have exhausted all therapeutic options) receive 650 mg Acetaminophen and 50 mg Benadryl orally 30 minutes prior to MV-NIS then receive MV-NIS IV over 1 hour on day 1.	Phase II (Acetaminophen + Benadryl + MV-NIS) Cohort B Cohort B patients (relapsing from VGPR or CR and have not \> received myeloma directed therapy for at least 12 weeks) receive 650 mg Acetaminophen and 50 mg Benadryl orally 30 minutes prior to MV-NIS then receive MV-NIS IV over 1 hour on day 1.
Overall Study STARTED	3	3	3	4	4	7	3	3	2	12	4
Overall Study COMPLETED	3	3	3	3	3	6	3	3	2	11	4
Overall Study NOT COMPLETED	0	0	0	1	1	1	0	0	0	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Phase I: Stage 1 (MV-NIS Alone) Dose Level 1 Patients receive 1x10\^6 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 1 (MV-NIS Alone) Dose Level 2 Patients receive 1x10\^7 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 1 (MV-NIS Alone) Dose Level 3 Patients receive 1x10\^8 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 1 (MV-NIS Alone) Dose Level 4 Patients receive 1x10\^9 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 1 (MV-NIS Alone) Dose Level 5 Patients receive 1x10\^10 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 1 (MV-NIS Alone) Dose Level 6 Patients receive 1x10\^11 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 1 Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then (Stage 1 MTD/100=10\^7) MV-NIS (TCID50) IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)	Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 2 Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then 3 x 10\^7 MV-NIS (TCID50) IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)	Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 3 Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then 9 x 10\^7 MV-NIS (TCID50) IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)	Phase II (Acetaminophen + Benadryl + MV-NIS) Cohort A Cohort A patients (relapsed or refractory multiple myeloma who have exhausted all therapeutic options) receive 650 mg Acetaminophen and 50 mg Benadryl orally 30 minutes prior to MV-NIS then receive MV-NIS IV over 1 hour on day 1.	Phase II (Acetaminophen + Benadryl + MV-NIS) Cohort B Cohort B patients (relapsing from VGPR or CR and have not \> received myeloma directed therapy for at least 12 weeks) receive 650 mg Acetaminophen and 50 mg Benadryl orally 30 minutes prior to MV-NIS then receive MV-NIS IV over 1 hour on day 1.
Overall Study Failed to complete the initial therapy	0	0	0	1	1	1	0	0	0	0	0
Overall Study Patient withdrawal prior to treatment	0	0	0	0	0	0	0	0	0	1	0

Baseline Characteristics

Vaccine Therapy With or Without Cyclophosphamide in Treating Patients With Recurrent or Refractory Multiple Myeloma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase I: Stage 1 (MV-NIS Alone) Dose Level 1 n=3 Participants Patients receive 1x10\^6 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 1 (MV-NIS Alone) Dose Level 2 n=3 Participants Patients receive 1x10\^7 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 1 (MV-NIS Alone) Dose Level 3 n=3 Participants Patients receive 1x10\^8 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 1 (MV-NIS Alone) Dose Level 4 n=3 Participants Patients receive 1x10\^9 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 1 (MV-NIS Alone) Dose Level 5 n=3 Participants Patients receive 1x10\^10 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 1 (MV-NIS Alone) Dose Level 6 n=6 Participants Patients receive 1x10\^11 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 1 n=3 Participants Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then (Stage 1 MTD/100=10\^7) MV-NIS (TCID50) IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)	Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 2 n=3 Participants Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then 3 x 10\^7 MV-NIS (TCID50) IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)	Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 3 n=2 Participants Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then 9 x 10\^7 MV-NIS (TCID50) IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)	Phase II (Acetaminophen + Benadryl + MV-NIS) n=15 Participants Patients receive 650 mg Acetaminophen and 50 mg Benadryl orally 30 minutes prior to MV-NIS then receive MV-NIS IV over 1 hour on day 1.	Total n=44 Participants Total of all reporting groups
Age, Continuous	64 years n=5 Participants	66 years n=7 Participants	51 years n=5 Participants	65 years n=4 Participants	63 years n=21 Participants	59 years n=10 Participants	62 years n=115 Participants	60 years n=6 Participants	65 years n=6 Participants	59 years n=64 Participants	60 years n=17 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	5 Participants n=10 Participants	1 Participants n=115 Participants	1 Participants n=6 Participants	0 Participants n=6 Participants	4 Participants n=64 Participants	18 Participants n=17 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants	1 Participants n=10 Participants	2 Participants n=115 Participants	2 Participants n=6 Participants	2 Participants n=6 Participants	11 Participants n=64 Participants	26 Participants n=17 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants	0 Participants n=17 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants	0 Participants n=17 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants	0 Participants n=17 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	1 Participants n=64 Participants	1 Participants n=17 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	6 Participants n=10 Participants	3 Participants n=115 Participants	3 Participants n=6 Participants	2 Participants n=6 Participants	13 Participants n=64 Participants	42 Participants n=17 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants	0 Participants n=17 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	1 Participants n=64 Participants	1 Participants n=17 Participants
ECOG Performance Status 0	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants	5 Participants n=10 Participants	2 Participants n=115 Participants	2 Participants n=6 Participants	1 Participants n=6 Participants	9 Participants n=64 Participants	23 Participants n=17 Participants
ECOG Performance Status 1	2 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants	0 Participants n=115 Participants	1 Participants n=6 Participants	1 Participants n=6 Participants	5 Participants n=64 Participants	15 Participants n=17 Participants
ECOG Performance Status 2	1 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	1 Participants n=64 Participants	6 Participants n=17 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: Only phase I patients who completed the study are included in this analysis.

Outcome measures

Outcome measures
Measure	Phase I: Stage 1 (MV-NIS Alone) Dose Level 1 n=3 Participants Patients receive 1x10\^6 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 1 (MV-NIS Alone) Dose Level 2 n=3 Participants Patients receive 1x10\^7 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 1 (MV-NIS Alone) Dose Level 3 n=3 Participants Patients receive 1x10\^8 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 1 (MV-NIS Alone) Dose Level 4 n=3 Participants Patients receive 1x10\^9 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 1 (MV-NIS Alone) Dose Level 5 n=3 Participants Patients receive 1x10\^10 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 1 (MV-NIS Alone) Dose Level 6 n=6 Participants Patients receive 1x10\^11 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 1 n=3 Participants Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then (Stage 1 MTD/100=10\^7) MV-NIS (TCID50) IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)	Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 2 n=3 Participants Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then 3 x 10\^7 MV-NIS (TCID50) IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)	Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 3 n=2 Participants Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then 9 x 10\^7 MV-NIS (TCID50) IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)
Number of Phase I Participants With Dose-Limiting Toxicity Events (Phase I)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: Only phase I stage 1 patients who completed the study are included in this analysis. Dose levels 1-6 of Phase I Stage 1 patients were combined in this analysis to determine the MTD as defined above.

Outcome measures

Outcome measures
Measure	Phase I: Stage 1 (MV-NIS Alone) Dose Level 1 n=21 Participants Patients receive 1x10\^6 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 1 (MV-NIS Alone) Dose Level 2 Patients receive 1x10\^7 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 1 (MV-NIS Alone) Dose Level 3 Patients receive 1x10\^8 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 1 (MV-NIS Alone) Dose Level 4 Patients receive 1x10\^9 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 1 (MV-NIS Alone) Dose Level 5 Patients receive 1x10\^10 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 1 (MV-NIS Alone) Dose Level 6 Patients receive 1x10\^11 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 1 Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then (Stage 1 MTD/100=10\^7) MV-NIS (TCID50) IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)	Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 2 Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then 3 x 10\^7 MV-NIS (TCID50) IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)	Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 3 Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then 9 x 10\^7 MV-NIS (TCID50) IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)
Maximum Tolerated Dose (MTD) (Phase I)	6 Dose Level	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Up to 1 year

Population: Only phase II patients who completed the study are included in this analysis. Phase II Cohort A and Phase II Cohort B were combined for this analysis due to accrual terminating early in Cohort B.

Confirmed response will be evaluated using all cycles. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

Outcome measures

Outcome measures
Measure	Phase I: Stage 1 (MV-NIS Alone) Dose Level 1 n=15 Participants Patients receive 1x10\^6 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 1 (MV-NIS Alone) Dose Level 2 Patients receive 1x10\^7 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 1 (MV-NIS Alone) Dose Level 3 Patients receive 1x10\^8 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 1 (MV-NIS Alone) Dose Level 4 Patients receive 1x10\^9 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 1 (MV-NIS Alone) Dose Level 5 Patients receive 1x10\^10 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 1 (MV-NIS Alone) Dose Level 6 Patients receive 1x10\^11 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 1 Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then (Stage 1 MTD/100=10\^7) MV-NIS (TCID50) IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)	Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 2 Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then 3 x 10\^7 MV-NIS (TCID50) IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)	Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 3 Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then 9 x 10\^7 MV-NIS (TCID50) IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)
Proportion of Confirmed Response, Defined as a Partial Response (PR) or Better (Phase II)	0 proportion of patients	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to 1 year

Population: Per protocol, Phase I specified secondary endpoint is evaluated for each STAGE independently; thus, the stage 1 dose level groups were combined and the stage 2 dose level groups were combined for this analysis PER PROTOCOL.

The overall toxicity rates (percentages) for grade 3 or higher adverse events considered at least possibly related to treatment are reported below by stage for Phase I patients.

Outcome measures

Outcome measures
Measure	Phase I: Stage 1 (MV-NIS Alone) Dose Level 1 n=21 Participants Patients receive 1x10\^6 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 1 (MV-NIS Alone) Dose Level 2 n=8 Participants Patients receive 1x10\^7 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 1 (MV-NIS Alone) Dose Level 3 Patients receive 1x10\^8 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 1 (MV-NIS Alone) Dose Level 4 Patients receive 1x10\^9 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 1 (MV-NIS Alone) Dose Level 5 Patients receive 1x10\^10 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 1 (MV-NIS Alone) Dose Level 6 Patients receive 1x10\^11 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 1 Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then (Stage 1 MTD/100=10\^7) MV-NIS (TCID50) IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)	Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 2 Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then 3 x 10\^7 MV-NIS (TCID50) IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)	Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 3 Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then 9 x 10\^7 MV-NIS (TCID50) IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)
Overall Toxicity Rate, Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0 (NCI CTCAE v3.0) (Phase I)	38 percentage of patients	25 percentage of patients	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to 1 year

The number of patients with clinical responses (CR, VGPR, PR, or minimal response \[MR\]) will be summarized by stage.

Outcome measures

Outcome measures
Measure	Phase I: Stage 1 (MV-NIS Alone) Dose Level 1 n=21 Participants Patients receive 1x10\^6 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 1 (MV-NIS Alone) Dose Level 2 n=8 Participants Patients receive 1x10\^7 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 1 (MV-NIS Alone) Dose Level 3 Patients receive 1x10\^8 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 1 (MV-NIS Alone) Dose Level 4 Patients receive 1x10\^9 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 1 (MV-NIS Alone) Dose Level 5 Patients receive 1x10\^10 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 1 (MV-NIS Alone) Dose Level 6 Patients receive 1x10\^11 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 1 Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then (Stage 1 MTD/100=10\^7) MV-NIS (TCID50) IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)	Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 2 Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then 3 x 10\^7 MV-NIS (TCID50) IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)	Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 3 Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then 9 x 10\^7 MV-NIS (TCID50) IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)
Number of Patients With Clinical Responses (Phase I)	1 Participants	0 Participants	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Time from registration to death due to any cause, assessed up to 1 year

Time from registration to death due to any cause, assessed up to 1 year. The distribution of survival time will be estimated using the method of Kaplan-Meier.

Outcome measures

Outcome measures
Measure	Phase I: Stage 1 (MV-NIS Alone) Dose Level 1 n=15 Participants Patients receive 1x10\^6 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 1 (MV-NIS Alone) Dose Level 2 Patients receive 1x10\^7 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 1 (MV-NIS Alone) Dose Level 3 Patients receive 1x10\^8 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 1 (MV-NIS Alone) Dose Level 4 Patients receive 1x10\^9 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 1 (MV-NIS Alone) Dose Level 5 Patients receive 1x10\^10 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 1 (MV-NIS Alone) Dose Level 6 Patients receive 1x10\^11 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 1 Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then (Stage 1 MTD/100=10\^7) MV-NIS (TCID50) IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)	Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 2 Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then 3 x 10\^7 MV-NIS (TCID50) IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)	Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 3 Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then 9 x 10\^7 MV-NIS (TCID50) IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)
Overall Survival (Phase II)	12.0 months Interval 5.6 to The 95% confidence interval upper limit has not been reached. (insufficient number of participants with events)	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Time from registration to the earliest date with documentation of disease progression, assessed up to 1 year

Population: Phase II specified secondary endpoint will only include Phase II patients. Phase II Cohort A and Phase II Cohort B were combined for this analysis due to accrual terminating in Cohort B early and to get the overall TTP for Phase II patients.

Time from registration to the earliest date with documentation of disease progression, assessed up to 1 year. The distribution of time to progression will be estimated using the method of Kaplan-Meier.

Outcome measures

Outcome measures
Measure	Phase I: Stage 1 (MV-NIS Alone) Dose Level 1 n=15 Participants Patients receive 1x10\^6 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 1 (MV-NIS Alone) Dose Level 2 Patients receive 1x10\^7 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 1 (MV-NIS Alone) Dose Level 3 Patients receive 1x10\^8 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 1 (MV-NIS Alone) Dose Level 4 Patients receive 1x10\^9 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 1 (MV-NIS Alone) Dose Level 5 Patients receive 1x10\^10 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 1 (MV-NIS Alone) Dose Level 6 Patients receive 1x10\^11 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 1 Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then (Stage 1 MTD/100=10\^7) MV-NIS (TCID50) IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)	Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 2 Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then 3 x 10\^7 MV-NIS (TCID50) IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)	Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 3 Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then 9 x 10\^7 MV-NIS (TCID50) IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)
Time to Progression (TTP) (Phase II)	1.48 months Interval 1.35 to 240.0	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: At 1 year

1-year progression-free survival (PFS1). Evidence of local recurrence, distant metastasis, or death from any cause within 1 year counted as events in the time-to-event Kaplan-Meier analysis of progression-free survival. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

Outcome measures

Outcome measures
Measure	Phase I: Stage 1 (MV-NIS Alone) Dose Level 1 n=15 Participants Patients receive 1x10\^6 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 1 (MV-NIS Alone) Dose Level 2 Patients receive 1x10\^7 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 1 (MV-NIS Alone) Dose Level 3 Patients receive 1x10\^8 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 1 (MV-NIS Alone) Dose Level 4 Patients receive 1x10\^9 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 1 (MV-NIS Alone) Dose Level 5 Patients receive 1x10\^10 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 1 (MV-NIS Alone) Dose Level 6 Patients receive 1x10\^11 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 1 Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then (Stage 1 MTD/100=10\^7) MV-NIS (TCID50) IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)	Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 2 Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then 3 x 10\^7 MV-NIS (TCID50) IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)	Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 3 Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then 9 x 10\^7 MV-NIS (TCID50) IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)
Progression-free Survival (Phase II)	6.7 percentage of patients	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: At 2 years

2-year progression-free survival (PFS2). Evidence of local recurrence, distant metastasis, or death from any cause within 2 years counted as events in the time-to-event Kaplan-Meier analysis of progression-free survival. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

Outcome measures

Outcome measures
Measure	Phase I: Stage 1 (MV-NIS Alone) Dose Level 1 n=15 Participants Patients receive 1x10\^6 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 1 (MV-NIS Alone) Dose Level 2 Patients receive 1x10\^7 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 1 (MV-NIS Alone) Dose Level 3 Patients receive 1x10\^8 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 1 (MV-NIS Alone) Dose Level 4 Patients receive 1x10\^9 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 1 (MV-NIS Alone) Dose Level 5 Patients receive 1x10\^10 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 1 (MV-NIS Alone) Dose Level 6 Patients receive 1x10\^11 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 1 Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then (Stage 1 MTD/100=10\^7) MV-NIS (TCID50) IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)	Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 2 Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then 3 x 10\^7 MV-NIS (TCID50) IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)	Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 3 Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then 9 x 10\^7 MV-NIS (TCID50) IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)
Progression-free Survival (Phase II)	6.7 percentage of patients	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to 5 years

Progression free survival (PFS) is defined as the time from the date of randomization to the date of disease progression or death resulting from any cause, whichever comes first. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

Outcome measures

Outcome measures
Measure	Phase I: Stage 1 (MV-NIS Alone) Dose Level 1 n=15 Participants Patients receive 1x10\^6 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 1 (MV-NIS Alone) Dose Level 2 Patients receive 1x10\^7 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 1 (MV-NIS Alone) Dose Level 3 Patients receive 1x10\^8 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 1 (MV-NIS Alone) Dose Level 4 Patients receive 1x10\^9 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 1 (MV-NIS Alone) Dose Level 5 Patients receive 1x10\^10 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 1 (MV-NIS Alone) Dose Level 6 Patients receive 1x10\^11 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 1 Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then (Stage 1 MTD/100=10\^7) MV-NIS (TCID50) IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)	Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 2 Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then 3 x 10\^7 MV-NIS (TCID50) IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)	Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 3 Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then 9 x 10\^7 MV-NIS (TCID50) IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)
Progression-free Survival (Phase II)	1.48 months Interval 1.35 to 2.4	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Time from registration to the earliest of progressive disease, alternative treatment for myeloma, or death due to any cause, assessed up to 1 year

Time from registration to the earliest of progressive disease, alternative treatment for myeloma, or death due to any cause, assessed up to 1 year. The distribution of failure-free survival will be estimated using the method of Kaplan-Meier.

Outcome measures

Outcome measures
Measure	Phase I: Stage 1 (MV-NIS Alone) Dose Level 1 n=15 Participants Patients receive 1x10\^6 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 1 (MV-NIS Alone) Dose Level 2 Patients receive 1x10\^7 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 1 (MV-NIS Alone) Dose Level 3 Patients receive 1x10\^8 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 1 (MV-NIS Alone) Dose Level 4 Patients receive 1x10\^9 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 1 (MV-NIS Alone) Dose Level 5 Patients receive 1x10\^10 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 1 (MV-NIS Alone) Dose Level 6 Patients receive 1x10\^11 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 1 Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then (Stage 1 MTD/100=10\^7) MV-NIS (TCID50) IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)	Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 2 Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then 3 x 10\^7 MV-NIS (TCID50) IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)	Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 3 Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then 9 x 10\^7 MV-NIS (TCID50) IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)
Failure-free Survival (Phase II)	1.4783 months Interval 1.2155 to 2.3982	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to 1 year

The overall toxicity rates (percentages) for grade 3 or higher adverse events considered at least possibly related to treatment are reported below for Phase II patients.

Outcome measures

Outcome measures
Measure	Phase I: Stage 1 (MV-NIS Alone) Dose Level 1 n=15 Participants Patients receive 1x10\^6 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 1 (MV-NIS Alone) Dose Level 2 Patients receive 1x10\^7 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 1 (MV-NIS Alone) Dose Level 3 Patients receive 1x10\^8 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 1 (MV-NIS Alone) Dose Level 4 Patients receive 1x10\^9 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 1 (MV-NIS Alone) Dose Level 5 Patients receive 1x10\^10 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 1 (MV-NIS Alone) Dose Level 6 Patients receive 1x10\^11 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 1 Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then (Stage 1 MTD/100=10\^7) MV-NIS (TCID50) IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)	Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 2 Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then 3 x 10\^7 MV-NIS (TCID50) IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)	Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 3 Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then 9 x 10\^7 MV-NIS (TCID50) IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)
Overall Toxicity Rate, Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0 (NCI CTCAE v3.0) (Phase II)	73.3 percentage of patients	—	—	—	—	—	—	—	—

Timeframe: Up to 6 weeks

Outcome measures

Other events: 15 other events

Deaths: 6 deaths

Serious adverse events

Serious adverse events
Measure	Phase I: Stage 1 (MV-NIS Alone) Dose Level 1 n=3 participants at risk Patients receive 1x10\^6 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 1 (MV-NIS Alone) Dose Level 2 n=3 participants at risk Patients receive 1x10\^7 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 1 (MV-NIS Alone) Dose Level 3 n=3 participants at risk Patients receive 1x10\^8 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 1 (MV-NIS Alone) Dose Level 4 n=4 participants at risk Patients receive 1x10\^9 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 1 (MV-NIS Alone) Dose Level 5 n=4 participants at risk Patients receive 1x10\^10 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 1 (MV-NIS Alone) Dose Level 6 n=7 participants at risk Patients receive 1x10\^11 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 1 n=3 participants at risk Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then (Stage 1 MTD/100=10\^7) MV-NIS (TCID50) IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)	Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 2 n=3 participants at risk Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then 3 x 10\^7 MV-NIS (TCID50) IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)	Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 3 n=2 participants at risk Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then 9 x 10\^7 MV-NIS (TCID50) IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)	Phase II (Acetaminophen + Benadryl + MV-NIS) n=15 participants at risk Patients receive 650 mg Acetaminophen and 50 mg Benadryl orally 30 minutes prior to MV-NIS then receive MV-NIS IV over 1 hour on day 1.
Gastrointestinal disorders Nausea	33.3% 1/3 • Number of events 1 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/7 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/2 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/15 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.
Blood and lymphatic system disorders Hemoglobin decreased	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/7 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/2 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	6.7% 1/15 • Number of events 1 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.
Cardiac disorders Restrictive cardiomyopathy	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	25.0% 1/4 • Number of events 1 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/7 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/2 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/15 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.
Gastrointestinal disorders Duodenal hemorrhage	33.3% 1/3 • Number of events 1 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/7 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/2 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/15 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.
Gastrointestinal disorders Vomiting	33.3% 1/3 • Number of events 1 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/7 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/2 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/15 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.
General disorders Fever	33.3% 1/3 • Number of events 1 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/7 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/2 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/15 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.
Investigations Neutrophil count decreased	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	14.3% 1/7 • Number of events 1 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/2 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/15 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.
Investigations Platelet count decreased	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	25.0% 1/4 • Number of events 1 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/7 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/2 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/15 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.
Metabolism and nutrition disorders Dehydration	33.3% 1/3 • Number of events 1 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/7 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/2 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/15 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	25.0% 1/4 • Number of events 1 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/7 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/2 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/15 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.

Other adverse events

Other adverse events
Measure	Phase I: Stage 1 (MV-NIS Alone) Dose Level 1 n=3 participants at risk Patients receive 1x10\^6 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 1 (MV-NIS Alone) Dose Level 2 n=3 participants at risk Patients receive 1x10\^7 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 1 (MV-NIS Alone) Dose Level 3 n=3 participants at risk Patients receive 1x10\^8 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 1 (MV-NIS Alone) Dose Level 4 n=4 participants at risk Patients receive 1x10\^9 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 1 (MV-NIS Alone) Dose Level 5 n=4 participants at risk Patients receive 1x10\^10 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 1 (MV-NIS Alone) Dose Level 6 n=7 participants at risk Patients receive 1x10\^11 MV-NIS (TCID50) IV over 1 hour on day 1.	Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 1 n=3 participants at risk Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then (Stage 1 MTD/100=10\^7) MV-NIS (TCID50) IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)	Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 2 n=3 participants at risk Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then 3 x 10\^7 MV-NIS (TCID50) IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)	Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 3 n=2 participants at risk Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then 9 x 10\^7 MV-NIS (TCID50) IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)	Phase II (Acetaminophen + Benadryl + MV-NIS) n=15 participants at risk Patients receive 650 mg Acetaminophen and 50 mg Benadryl orally 30 minutes prior to MV-NIS then receive MV-NIS IV over 1 hour on day 1.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/7 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/2 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	13.3% 2/15 • Number of events 2 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	25.0% 1/4 • Number of events 1 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	14.3% 1/7 • Number of events 1 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/2 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	6.7% 1/15 • Number of events 2 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.
Blood and lymphatic system disorders Hemoglobin decreased	100.0% 3/3 • Number of events 8 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	100.0% 3/3 • Number of events 10 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	100.0% 3/3 • Number of events 7 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	75.0% 3/4 • Number of events 4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	100.0% 4/4 • Number of events 7 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	100.0% 7/7 • Number of events 13 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	100.0% 3/3 • Number of events 12 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	100.0% 3/3 • Number of events 10 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	100.0% 2/2 • Number of events 8 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	100.0% 15/15 • Number of events 23 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.
Cardiac disorders Left ventricular failure	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/7 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	50.0% 1/2 • Number of events 1 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/15 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.
Cardiac disorders Sinus bradycardia	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/7 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/2 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	6.7% 1/15 • Number of events 1 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.
Endocrine disorders Hypothyroidism	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	25.0% 1/4 • Number of events 1 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	14.3% 1/7 • Number of events 1 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/2 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	6.7% 1/15 • Number of events 1 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.
Eye disorders Photophobia	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	14.3% 1/7 • Number of events 1 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/2 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/15 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.
Gastrointestinal disorders Diarrhea	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	33.3% 1/3 • Number of events 1 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	25.0% 1/4 • Number of events 1 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	75.0% 3/4 • Number of events 4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	42.9% 3/7 • Number of events 4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	33.3% 1/3 • Number of events 1 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	66.7% 2/3 • Number of events 2 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	50.0% 1/2 • Number of events 1 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	66.7% 10/15 • Number of events 11 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.
Gastrointestinal disorders Ear, nose and throat examination abnormal	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/7 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/2 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	6.7% 1/15 • Number of events 1 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.
Gastrointestinal disorders Nausea	33.3% 1/3 • Number of events 1 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	66.7% 2/3 • Number of events 4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	66.7% 2/3 • Number of events 2 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	25.0% 1/4 • Number of events 1 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	75.0% 3/4 • Number of events 5 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	71.4% 5/7 • Number of events 5 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	66.7% 2/3 • Number of events 2 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	100.0% 3/3 • Number of events 4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	100.0% 2/2 • Number of events 4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	80.0% 12/15 • Number of events 14 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.
Gastrointestinal disorders Vomiting	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	100.0% 3/3 • Number of events 4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	75.0% 3/4 • Number of events 3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	28.6% 2/7 • Number of events 2 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	33.3% 1/3 • Number of events 1 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/2 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	53.3% 8/15 • Number of events 9 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.
General disorders Chills	33.3% 1/3 • Number of events 1 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	66.7% 2/3 • Number of events 3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	25.0% 1/4 • Number of events 1 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	75.0% 3/4 • Number of events 3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	71.4% 5/7 • Number of events 5 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	33.3% 1/3 • Number of events 1 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/2 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	73.3% 11/15 • Number of events 12 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.
General disorders Fatigue	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/7 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/2 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	6.7% 1/15 • Number of events 1 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.
General disorders Fever	33.3% 1/3 • Number of events 3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	25.0% 1/4 • Number of events 1 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	50.0% 2/4 • Number of events 3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	85.7% 6/7 • Number of events 6 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	33.3% 1/3 • Number of events 1 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	50.0% 1/2 • Number of events 1 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	86.7% 13/15 • Number of events 13 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.
General disorders Injection site reaction	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/7 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/2 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	6.7% 1/15 • Number of events 1 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.
General disorders Pain	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	14.3% 1/7 • Number of events 1 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/2 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	6.7% 1/15 • Number of events 1 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.
Immune system disorders Cytokine release syndrome	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	42.9% 3/7 • Number of events 3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/2 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	6.7% 1/15 • Number of events 1 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.
Infections and infestations Infection	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	25.0% 1/4 • Number of events 1 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/7 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/2 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	6.7% 1/15 • Number of events 1 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.
Infections and infestations Peripheral nerve infection	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/7 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/2 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	6.7% 1/15 • Number of events 1 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.
Infections and infestations Phlebitis infective	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	14.3% 1/7 • Number of events 1 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/2 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/15 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.
Infections and infestations Sinusitis	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	14.3% 1/7 • Number of events 1 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/2 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/15 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.
Infections and infestations Skin infection	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	14.3% 1/7 • Number of events 1 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/2 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/15 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.
Infections and infestations Upper respiratory infection	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	25.0% 1/4 • Number of events 1 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	14.3% 1/7 • Number of events 1 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	50.0% 1/2 • Number of events 1 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	26.7% 4/15 • Number of events 4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.
Injury, poisoning and procedural complications Fracture	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/7 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	33.3% 1/3 • Number of events 1 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/2 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/15 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.
Investigations Activated partial thromboplastin time prolonged	33.3% 1/3 • Number of events 1 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/7 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/2 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/15 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.
Investigations Aspartate aminotransferase increased	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	25.0% 1/4 • Number of events 1 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/7 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/2 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/15 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.
Investigations CD4 lymphocytes decreased	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	14.3% 1/7 • Number of events 1 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/2 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	13.3% 2/15 • Number of events 2 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.
Investigations Creatinine increased	100.0% 3/3 • Number of events 4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	66.7% 2/3 • Number of events 6 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	33.3% 1/3 • Number of events 1 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	50.0% 2/4 • Number of events 3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	75.0% 3/4 • Number of events 7 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	14.3% 1/7 • Number of events 1 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	66.7% 2/3 • Number of events 4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	33.3% 1/3 • Number of events 2 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	50.0% 1/2 • Number of events 4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	46.7% 7/15 • Number of events 11 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.
Investigations Electrocardiogram QTc interval prolonged	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/7 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/2 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	6.7% 1/15 • Number of events 1 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.
Investigations Leukocyte count decreased	66.7% 2/3 • Number of events 4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	100.0% 3/3 • Number of events 5 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	100.0% 3/3 • Number of events 5 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	75.0% 3/4 • Number of events 4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	75.0% 3/4 • Number of events 4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	100.0% 7/7 • Number of events 8 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	66.7% 2/3 • Number of events 3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	100.0% 3/3 • Number of events 6 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	100.0% 2/2 • Number of events 8 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	73.3% 11/15 • Number of events 11 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.
Investigations Lymphocyte count decreased	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	25.0% 1/4 • Number of events 1 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/7 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	100.0% 3/3 • Number of events 6 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	66.7% 2/3 • Number of events 4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	100.0% 2/2 • Number of events 2 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	33.3% 5/15 • Number of events 5 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.
Investigations Neutrophil count decreased	66.7% 2/3 • Number of events 4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	100.0% 3/3 • Number of events 6 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	100.0% 3/3 • Number of events 5 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	25.0% 1/4 • Number of events 1 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	75.0% 3/4 • Number of events 4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	85.7% 6/7 • Number of events 10 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	100.0% 3/3 • Number of events 4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	66.7% 2/3 • Number of events 5 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	100.0% 2/2 • Number of events 6 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	60.0% 9/15 • Number of events 12 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.
Investigations Platelet count decreased	100.0% 3/3 • Number of events 8 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	100.0% 3/3 • Number of events 9 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	100.0% 3/3 • Number of events 6 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	25.0% 1/4 • Number of events 1 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	100.0% 4/4 • Number of events 7 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	100.0% 7/7 • Number of events 7 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	100.0% 3/3 • Number of events 6 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	100.0% 3/3 • Number of events 10 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	100.0% 2/2 • Number of events 8 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	86.7% 13/15 • Number of events 13 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.
Metabolism and nutrition disorders Anorexia	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	25.0% 1/4 • Number of events 1 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/7 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/2 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	6.7% 1/15 • Number of events 1 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.
Metabolism and nutrition disorders Dehydration	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/7 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/2 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	6.7% 1/15 • Number of events 1 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.
Metabolism and nutrition disorders Hypercalcemia	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	33.3% 1/3 • Number of events 1 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	25.0% 1/4 • Number of events 1 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/7 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	33.3% 1/3 • Number of events 1 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/2 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	6.7% 1/15 • Number of events 1 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/7 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	33.3% 1/3 • Number of events 1 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/2 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/15 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.
Metabolism and nutrition disorders Hyperkalemia	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	25.0% 1/4 • Number of events 1 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/7 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/2 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/15 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.
Metabolism and nutrition disorders Hyperuricemia	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	25.0% 1/4 • Number of events 1 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/7 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/2 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/15 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.
Metabolism and nutrition disorders Hypocalcemia	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/7 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/2 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	6.7% 1/15 • Number of events 1 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.
Metabolism and nutrition disorders Hypokalemia	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/7 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	50.0% 1/2 • Number of events 1 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/15 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	25.0% 1/4 • Number of events 1 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/7 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	50.0% 1/2 • Number of events 1 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/15 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.
Nervous system disorders Syncope	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/7 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	33.3% 1/3 • Number of events 1 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/2 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/15 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	25.0% 1/4 • Number of events 1 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/7 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/2 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/15 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.
Musculoskeletal and connective tissue disorders Joint pain	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/7 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	33.3% 1/3 • Number of events 1 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/2 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/15 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Treatment related secondary malignancy	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/7 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	33.3% 1/3 • Number of events 5 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/2 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/15 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.
Nervous system disorders Encephalopathy	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/7 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/2 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	13.3% 2/15 • Number of events 2 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.
Nervous system disorders Headache	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	14.3% 1/7 • Number of events 1 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/2 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	26.7% 4/15 • Number of events 4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.
Nervous system disorders Taste alteration	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	14.3% 1/7 • Number of events 1 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/2 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/15 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.
Psychiatric disorders Confusion	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/7 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/2 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	6.7% 1/15 • Number of events 1 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.
Psychiatric disorders Insomnia	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/7 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/2 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	6.7% 1/15 • Number of events 1 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.
Renal and urinary disorders Renal failure	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	25.0% 1/4 • Number of events 1 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/7 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/2 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/15 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.
Respiratory, thoracic and mediastinal disorders Cough	100.0% 3/3 • Number of events 3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	33.3% 1/3 • Number of events 1 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	25.0% 1/4 • Number of events 1 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	50.0% 2/4 • Number of events 3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	42.9% 3/7 • Number of events 5 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	33.3% 1/3 • Number of events 1 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	66.7% 2/3 • Number of events 3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	100.0% 2/2 • Number of events 4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	66.7% 10/15 • Number of events 10 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/7 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/2 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	20.0% 3/15 • Number of events 3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.
Skin and subcutaneous tissue disorders Rash desquamating	66.7% 2/3 • Number of events 3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	25.0% 1/4 • Number of events 1 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	25.0% 1/4 • Number of events 1 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	28.6% 2/7 • Number of events 2 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	33.3% 1/3 • Number of events 1 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	33.3% 1/3 • Number of events 1 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/2 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	26.7% 4/15 • Number of events 4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.
Vascular disorders Hemorrhage	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/7 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/2 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	6.7% 1/15 • Number of events 1 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.
Vascular disorders Hypotension	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	28.6% 2/7 • Number of events 2 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/2 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	13.3% 2/15 • Number of events 2 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.
Vascular disorders Thrombosis	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/4 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/7 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/3 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	0.00% 0/2 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.	6.7% 1/15 • Number of events 1 • Up to 1 year Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.

Additional Information

Angela Dispenzieri, M.D., Morie A. Gertz, M.D.

Mayo Clinic

Phone: (507) 284-2511

Email: [email protected], [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place