Trial Outcomes & Findings for Eltrombopag in Elderly Acute Myelogenous Leukemia (AML) (NCT NCT01113502)

NCT ID: NCT01113502

Last Updated: 2021-08-05

Results Overview

The maximal tolerated dose of eltrombopag for elderly subjects with AML will be defined as the number of dose limiting toxicities per dosing level.

• Recruitment status: TERMINATED
• Study phase: PHASE1/PHASE2
• Target enrollment: 44 participants
• Primary outcome timeframe: The time from first day of therapy until subject is off study treatment, an average of 10 weeks.
• Results posted on: 2021-08-05

Participant Flow

Participant milestones

Measure	Phase I Dose Level I 50 mg Eltrombopag taken daily by mouth	Phase I Dose Level II 100 mg Eltrombopag taken daily by mouth	Phase I Dose Level III 200 mg Eltrombopag taken daily by mouth	Phase I Dose Level IV 300 mg Eltrombopag taken daily by mouth	Phase II Dose Level 2 weeks of 200 mg Eltrombopag taken daily by mouth, then 300 mg Eltrombopag taken daily by mouth
Overall Study STARTED	4	3	7	9	21
Overall Study COMPLETED	3	3	3	6	21
Overall Study NOT COMPLETED	1	0	4	3	0

Reasons for withdrawal

Measure	Phase I Dose Level I 50 mg Eltrombopag taken daily by mouth	Phase I Dose Level II 100 mg Eltrombopag taken daily by mouth	Phase I Dose Level III 200 mg Eltrombopag taken daily by mouth	Phase I Dose Level IV 300 mg Eltrombopag taken daily by mouth	Phase II Dose Level 2 weeks of 200 mg Eltrombopag taken daily by mouth, then 300 mg Eltrombopag taken daily by mouth
Overall Study Withdrawal by Subject	1	0	1	1	0
Overall Study Adverse Event	0	0	3	2	0

Baseline Characteristics

Eltrombopag in Elderly Acute Myelogenous Leukemia (AML)

Baseline characteristics by cohort

Measure	Phase I Dose Level I n=4 Participants 50mg Eltrombopag taken daily by mouth	Phase I Dose Level II n=3 Participants 100mg Eltrombopag taken daily by mouth	Phase I Dose Level III n=7 Participants 200mg Eltrombopag taken daily by mouth	Phase I Dose Level IV n=9 Participants 300mg Eltrombopag taken daily by mouth	Phase II n=21 Participants 2 weeks of 200mg Eltrombopag taken daily by mouth then 300mg Eltrombopag taken daily by mouth	Total n=44 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	4 Participants n=21 Participants	8 Participants n=8 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants	8 Participants n=4 Participants	17 Participants n=21 Participants	36 Participants n=8 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants	8 Participants n=21 Participants	16 Participants n=8 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants	5 Participants n=4 Participants	13 Participants n=21 Participants	28 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants	3 Participants n=4 Participants	5 Participants n=21 Participants	19 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	6 Participants n=4 Participants	16 Participants n=21 Participants	25 Participants n=8 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=8 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=8 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=8 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	4 Participants n=8 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	7 Participants n=4 Participants	11 Participants n=21 Participants	29 Participants n=8 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=8 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	9 Participants n=21 Participants	11 Participants n=8 Participants
Region of Enrollment United States	4 participants n=5 Participants	3 participants n=7 Participants	7 participants n=5 Participants	9 participants n=4 Participants	21 participants n=21 Participants	44 participants n=8 Participants

PRIMARY outcome

Timeframe: The time from first day of therapy until subject is off study treatment, an average of 10 weeks.

The maximal tolerated dose of eltrombopag for elderly subjects with AML will be defined as the number of dose limiting toxicities per dosing level.

Outcome measures

Measure	Phase I Dose Level I n=4 Participants 50 mg Eltrombopag taken daily by mouth	Phase I Dose Level II n=3 Participants 100 mg Eltrombopag taken daily by mouth	Phase I Dose Level III n=7 Participants 200 mg Eltrombopag taken daily by mouth	Phase I Dose Level IV n=9 Participants 300 mg Eltrombopag taken daily by mouth	Phase II Dose Level 2 weeks of 200 mg Eltrombopag taken daily by mouth, then 300 mg Eltrombopag taken daily by mouth
Maximally Tolerated Dose of Eltrombopag for Elderly Subjects With AML in Phase 1 Group	0 Dose Limiting Toxicities	0 Dose Limiting Toxicities	0 Dose Limiting Toxicities	1 Dose Limiting Toxicities	—

PRIMARY outcome

Timeframe: The time from first day of therapy to the first four weeks of therapy.

The tolerability of eltrombopag in elderly patients with AML at the maximally tolerated starting dose determined in Phase I portion of study will be assessed by the number of dose limiting toxicities in the Phase II dosing cohort. Clinical assessment and laboratory evaluation of Adverse Events and DLTs will be done according to the Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 of the National Cancer Institute (NCI) Cancer Therapy Evaluation Program (CTEP).

Outcome measures

Measure	Phase I Dose Level I n=21 Participants 50 mg Eltrombopag taken daily by mouth	Phase I Dose Level II 100 mg Eltrombopag taken daily by mouth	Phase I Dose Level III 200 mg Eltrombopag taken daily by mouth	Phase I Dose Level IV 300 mg Eltrombopag taken daily by mouth	Phase II Dose Level 2 weeks of 200 mg Eltrombopag taken daily by mouth, then 300 mg Eltrombopag taken daily by mouth
Tolerability of Maximum Dose in Phase II Cohort	0 Dose Limiting toxicities	—	—	—	—

PRIMARY outcome

Timeframe: First day of study treatment to 30 days after last study treatment, an average of 10 weeks.

Safety of eltrombopag will be measured as the number of Grade 3 or higher adverse events per dosing level in Phase 1 group related to Eltrombopag. Relatedness is defined as event being assessed as unlikely, possibly, probably and definitely related to Eltrombopag. All events meeting these assessment categories will be considered related, and those assessed as Grade 3 or higher are reported for each dose level.

Outcome measures

Measure	Phase I Dose Level I n=4 Participants 50 mg Eltrombopag taken daily by mouth	Phase I Dose Level II n=3 Participants 100 mg Eltrombopag taken daily by mouth	Phase I Dose Level III n=7 Participants 200 mg Eltrombopag taken daily by mouth	Phase I Dose Level IV n=9 Participants 300 mg Eltrombopag taken daily by mouth	Phase II Dose Level 2 weeks of 200 mg Eltrombopag taken daily by mouth, then 300 mg Eltrombopag taken daily by mouth
The Safety of Eltrombopag for Elderly Subjects With AML in Phase 1 Group	1 Related Adverse Events	0 Related Adverse Events	1 Related Adverse Events	6 Related Adverse Events	—

PRIMARY outcome

Timeframe: First day of study treatment to 30 days after last study treatment, an average of 7 weeks.

Safety of eltrombopag will be measured as the number of Serious Adverse Events in Phase II group related to Eltrombopag. Relatedness is defined as event being assessed as unlikely, possibly, probably and definitely related to Eltrombopag. All Serious Adverse Events meeting these assessment categories will be considered related and are reported for the Phase II cohort.

Outcome measures

Measure	Phase I Dose Level I n=21 Participants 50 mg Eltrombopag taken daily by mouth	Phase I Dose Level II 100 mg Eltrombopag taken daily by mouth	Phase I Dose Level III 200 mg Eltrombopag taken daily by mouth	Phase I Dose Level IV 300 mg Eltrombopag taken daily by mouth	Phase II Dose Level 2 weeks of 200 mg Eltrombopag taken daily by mouth, then 300 mg Eltrombopag taken daily by mouth
Safety of Eltrombopag in Patients With AML in Phase II Cohort.	0 Number of related Serious Adverse Events	—	—	—	—

PRIMARY outcome

Timeframe: First day of study treatment to 30 days after last study treatment, an average of 10 weeks.

Peripheral platelet count response is defined by number of participants in each dosing cohort exhibiting a peripheral platelet count response using the IWG modified Hematologic Improvement response criteria: For patients with counts less than 100,000/ul: 1) For patients with baseline platelet of > 20,000/ul, absolute increase of platelet count by at least 30,000 /ul 2) For patients with baseline platelets < 20,000/ul, an increase to > 20,000/ul and by at least 100%.

Outcome measures

Measure	Phase I Dose Level I n=4 Participants 50 mg Eltrombopag taken daily by mouth	Phase I Dose Level II n=3 Participants 100 mg Eltrombopag taken daily by mouth	Phase I Dose Level III n=7 Participants 200 mg Eltrombopag taken daily by mouth	Phase I Dose Level IV n=9 Participants 300 mg Eltrombopag taken daily by mouth	Phase II Dose Level 2 weeks of 200 mg Eltrombopag taken daily by mouth, then 300 mg Eltrombopag taken daily by mouth
Number of Participants With Peripheral Platelet Count Response in Phase I Cohort	0 Participants	0 Participants	2 Participants	2 Participants	—

SECONDARY outcome

Timeframe: The time from first day of therapy to time when subject achieves a complete remission (CR), based on the definition of the International Working Group (IWG), approximately 30 days.

This will include subjects who achieve a complete remission (CR) based on definitions by the International Working Group (IWG). CR is defined as the participant have a neutrophil Count>1000/ul, platelet count of >100,000/ul, bone Marrow Blasts < 5% and having no evidence of extramedullary disease.

Outcome measures

Measure	Phase I Dose Level I n=4 Participants 50 mg Eltrombopag taken daily by mouth	Phase I Dose Level II n=3 Participants 100 mg Eltrombopag taken daily by mouth	Phase I Dose Level III n=7 Participants 200 mg Eltrombopag taken daily by mouth	Phase I Dose Level IV n=9 Participants 300 mg Eltrombopag taken daily by mouth	Phase II Dose Level n=21 Participants 2 weeks of 200 mg Eltrombopag taken daily by mouth, then 300 mg Eltrombopag taken daily by mouth
Overall Response Rate (Phase I and Phase II)	0 Participants with a CR	0 Participants with a CR	0 Participants with a CR	1 Participants with a CR	0 Participants with a CR

Adverse Events

Phase I Dose Level I

Serious events: 3 serious events

Other events: 2 other events

Deaths: 2 deaths

Phase I Dose Level II

Serious events: 3 serious events

Other events: 0 other events

Deaths: 1 deaths

Phase I Dose Level III

Serious events: 7 serious events

Other events: 3 other events

Deaths: 3 deaths

Phase I Dose Level IV

Serious events: 7 serious events

Other events: 5 other events

Deaths: 2 deaths

Phase II Dose Level

Serious events: 9 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Phase I Dose Level I n=4 participants at risk 50 mg Eltrombopag taken daily by mouth	Phase I Dose Level II n=3 participants at risk 100 mg Eltrombopag taken daily by mouth	Phase I Dose Level III n=7 participants at risk 200 mg Eltrombopag taken daily by mouth	Phase I Dose Level IV n=9 participants at risk 300 mg Eltrombopag taken daily by mouth	Phase II Dose Level n=21 participants at risk 2 weeks of 200 mg Eltrombopag taken daily by mouth, then 300 mg Eltrombopag taken daily by mouth
Metabolism and nutrition disorders Dehydration	0.00% 0/4 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/3 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	14.3% 1/7 • Number of events 1 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/9 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/21 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.
Nervous system disorders Intracranial hemorrhage	0.00% 0/4 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/3 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	14.3% 1/7 • Number of events 1 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/9 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/21 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.
General disorders Neck edema	0.00% 0/4 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/3 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	14.3% 1/7 • Number of events 1 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/9 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/21 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.
Hepatobiliary disorders Cholecystitis	0.00% 0/4 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/3 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/7 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	11.1% 1/9 • Number of events 1 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/21 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.
Gastrointestinal disorders Anorexia	0.00% 0/4 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/3 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/7 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	11.1% 1/9 • Number of events 1 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/21 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.
Blood and lymphatic system disorders Disease progression	0.00% 0/4 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/3 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/7 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	11.1% 1/9 • Number of events 1 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/21 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.
General disorders Pain	0.00% 0/4 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/3 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/7 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	11.1% 1/9 • Number of events 1 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/21 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.
General disorders Fever	0.00% 0/4 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/3 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/7 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	11.1% 1/9 • Number of events 1 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/21 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.
Infections and infestations Anorectal infection	0.00% 0/4 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/3 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/7 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	11.1% 1/9 • Number of events 1 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/21 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/4 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/3 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/7 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	11.1% 1/9 • Number of events 1 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/21 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.
Infections and infestations Wound infection	0.00% 0/4 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/3 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/7 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/9 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	4.8% 1/21 • Number of events 1 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.
Investigations Thrombocytopenia	0.00% 0/4 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/3 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/7 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/9 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	4.8% 1/21 • Number of events 1 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/4 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/3 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/7 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/9 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	4.8% 1/21 • Number of events 1 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.
Psychiatric disorders Confusion	0.00% 0/4 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/3 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/7 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/9 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	4.8% 1/21 • Number of events 2 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.
Cardiac disorders Acute coronary syndrome	0.00% 0/4 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/3 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/7 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/9 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	4.8% 1/21 • Number of events 2 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.
Hepatobiliary disorders Hepatic failure	0.00% 0/4 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/3 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/7 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/9 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	4.8% 1/21 • Number of events 1 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.
Infections and infestations Bronchial Infection	0.00% 0/4 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/3 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/7 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/9 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	4.8% 1/21 • Number of events 1 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, Specify	25.0% 1/4 • Number of events 1 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/3 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/7 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/9 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/21 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.
Injury, poisoning and procedural complications Fall	25.0% 1/4 • Number of events 1 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/3 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/7 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/9 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/21 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.
Blood and lymphatic system disorders Febrile neutropenia	50.0% 2/4 • Number of events 3 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	33.3% 1/3 • Number of events 1 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	42.9% 3/7 • Number of events 4 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	22.2% 2/9 • Number of events 2 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	14.3% 3/21 • Number of events 4 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify	25.0% 1/4 • Number of events 1 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/3 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/7 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/9 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/21 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.
General disorders Death, NOS	25.0% 1/4 • Number of events 1 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/3 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/7 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/9 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/21 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specify	0.00% 0/4 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	33.3% 1/3 • Number of events 1 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/7 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/9 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/21 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.
General disorders Fatigue	0.00% 0/4 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	33.3% 1/3 • Number of events 1 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	14.3% 1/7 • Number of events 1 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/9 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/21 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.
Infections and infestations Sepsis	0.00% 0/4 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	33.3% 1/3 • Number of events 1 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	28.6% 2/7 • Number of events 2 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	11.1% 1/9 • Number of events 1 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/21 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.
Vascular disorders Hypotension	0.00% 0/4 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	33.3% 1/3 • Number of events 1 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	14.3% 1/7 • Number of events 1 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/9 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/21 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/4 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/3 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	14.3% 1/7 • Number of events 1 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/9 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	4.8% 1/21 • Number of events 1 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.
Infections and infestations Lung infection	0.00% 0/4 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/3 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	14.3% 1/7 • Number of events 1 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	11.1% 1/9 • Number of events 1 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	9.5% 2/21 • Number of events 2 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.

Other adverse events

Measure	Phase I Dose Level I n=4 participants at risk 50 mg Eltrombopag taken daily by mouth	Phase I Dose Level II n=3 participants at risk 100 mg Eltrombopag taken daily by mouth	Phase I Dose Level III n=7 participants at risk 200 mg Eltrombopag taken daily by mouth	Phase I Dose Level IV n=9 participants at risk 300 mg Eltrombopag taken daily by mouth	Phase II Dose Level n=21 participants at risk 2 weeks of 200 mg Eltrombopag taken daily by mouth, then 300 mg Eltrombopag taken daily by mouth
Blood and lymphatic system disorders Anemia	25.0% 1/4 • Number of events 1 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/3 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/7 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	33.3% 3/9 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/21 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.
Gastrointestinal disorders Diarrhea	0.00% 0/4 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/3 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	14.3% 1/7 • Number of events 2 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/9 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/21 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.
Vascular disorders Hypotension	0.00% 0/4 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/3 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	14.3% 1/7 • Number of events 1 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	11.1% 1/9 • Number of events 1 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/21 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.
Blood and lymphatic system disorders Neutropenia	25.0% 1/4 • Number of events 1 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/3 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/7 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/9 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/21 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.
Gastrointestinal disorders Pain, abdominal	0.00% 0/4 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/3 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	14.3% 1/7 • Number of events 1 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	11.1% 1/9 • Number of events 1 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/21 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.
Investigations White blood cell decrease	25.0% 1/4 • Number of events 1 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/3 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/7 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	11.1% 1/9 • Number of events 2 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/21 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.
Respiratory, thoracic and mediastinal disorders Aspiration Pneumonia	0.00% 0/4 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/3 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	28.6% 2/7 • Number of events 3 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/9 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/21 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.
Blood and lymphatic system disorders Thrombocytopenia	25.0% 1/4 • Number of events 1 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/3 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/7 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/9 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/21 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.
Investigations Activated PTT prolongation	0.00% 0/4 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/3 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/7 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	11.1% 1/9 • Number of events 3 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.	0.00% 0/21 • Adverse events were collected on each subject from the time of treatment initiation until 30 days after the last treatment administration, an average of 14 weeks for the Phase I cohort, and an average of 11 weeks for the Phase II cohort. Adverse event data for the total counts of the Phase II cohort is available, but the number of individual events per participant in this dosing group is not available. These data have been searched for in all the available reports and materials, requested from the PI, requested from institutional leadership, searched for in institutional clinical trial databases and medical records, but cannot be located.

Additional Information

Dr. Noelle Frey

Abramson Cancer Center of the University of Pennsylvania

Email: noelle.frey@pennmedicine.upenn.edu

Results disclosure agreements

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