Trial Outcomes & Findings for A Study of ABT-263 in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia (NCT NCT00481091)

Last Updated: 2023-06-13

Results Overview

An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An SAE is one that: results in death, hospitalization, prolongation of hospitalization, or persistent or significant disability/incapacity; is life-threatening, a congenital anomaly, or other important medical event. Events were graded as 1=mild, 2=moderate, 3=severe, 4=life-threatening, or 5=death. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A treatment-emergent adverse event is defined as any adverse event with onset or worsening reported by a subject from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug administration. Deaths category included non treatment emergent deaths.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

60 participants

Primary outcome timeframe

From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles.

Results posted on

2023-06-13

Participant Flow

Participant milestones

Participant milestones
Measure	Phase 2: Navitoclax 250 mg Navitoclax 250 mg in participants with CLL who had relapsed following any (but no more than 5) prior myelosuppressive/chemotherapy treatment regimen(s).	Phase 2: Navitoclax 100 mg Navitoclax 100 mg in participants with chronic lymphocytic leukemia (CLL) who had relapsed following any (but no more than 5) prior myelosuppressive/chemotherapy treatment regimen(s).	Navitoclax 14/21 Day Cycle: 10 mg Navitoclax 10 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.	Navitoclax 14/21 Day Cycle: 110 mg Navitoclax 110 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.	Navitoclax 14/21 Day Cycle: 200 mg Navitoclax 200 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.	Navitoclax 14/21 Day Cycle: 250 mg Navitoclax 250 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.	Navitoclax 21/21 Day Cycle: 125 mg Navitoclax 125 mg administered for 21 consecutive days to complete a 21-day cycle.	Navitoclax 21/21 Day Cycle: 200 mg Navitoclax 200 mg administered for 21 consecutive days to complete a 21-day cycle.	Navitoclax 21/21 Day Cycle: 250 mg Navitoclax 250 mg administered for 21 consecutive days to complete a 21-day cycle.	Navitoclax 21/21 Day Cycle: 300 mg Navitoclax 300 mg administered for 21 consecutive days to complete a 21-day cycle.
Overall Study STARTED	27	4	3	6	3	3	3	4	3	4
Overall Study COMPLETED	0	0	0	0	0	0	0	0	0	0
Overall Study NOT COMPLETED	27	4	3	6	3	3	3	4	3	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Phase 2: Navitoclax 250 mg Navitoclax 250 mg in participants with CLL who had relapsed following any (but no more than 5) prior myelosuppressive/chemotherapy treatment regimen(s).	Phase 2: Navitoclax 100 mg Navitoclax 100 mg in participants with chronic lymphocytic leukemia (CLL) who had relapsed following any (but no more than 5) prior myelosuppressive/chemotherapy treatment regimen(s).	Navitoclax 14/21 Day Cycle: 10 mg Navitoclax 10 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.	Navitoclax 14/21 Day Cycle: 110 mg Navitoclax 110 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.	Navitoclax 14/21 Day Cycle: 200 mg Navitoclax 200 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.	Navitoclax 14/21 Day Cycle: 250 mg Navitoclax 250 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.	Navitoclax 21/21 Day Cycle: 125 mg Navitoclax 125 mg administered for 21 consecutive days to complete a 21-day cycle.	Navitoclax 21/21 Day Cycle: 200 mg Navitoclax 200 mg administered for 21 consecutive days to complete a 21-day cycle.	Navitoclax 21/21 Day Cycle: 250 mg Navitoclax 250 mg administered for 21 consecutive days to complete a 21-day cycle.	Navitoclax 21/21 Day Cycle: 300 mg Navitoclax 300 mg administered for 21 consecutive days to complete a 21-day cycle.
Overall Study Withdrawal by Subject	6	1	0	1	1	0	0	0	0	0
Overall Study Other, Not Specified	4	0	0	1	1	0	0	1	0	0
Overall Study Adverse Event	6	1	1	2	0	1	1	1	2	1
Overall Study Progressive disease clinical	7	1	0	0	0	0	0	0	0	0
Overall Study Progressive disease clinical National Cancer Institute	0	0	1	1	0	0	0	1	0	0
Overall Study Progressive disease other	0	0	1	1	0	1	1	1	0	2
Overall Study No reason given	4	1	0	0	1	1	1	0	1	1

Baseline Characteristics

A Study of ABT-263 in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Navitoclax 14/21 Day Cycle: 10 mg n=3 Participants Navitoclax 10 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.	Navitoclax 14/21 Day Cycle: 110 mg n=6 Participants Navitoclax 110 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.	Navitoclax 14/21 Day Cycle: 200 mg n=3 Participants Navitoclax 200 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.	Navitoclax 14/21 Day Cycle: 250 mg n=3 Participants Navitoclax 250 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.	Navitoclax 21/21 Day Cycle: 125 mg n=3 Participants Navitoclax 125 mg administered for 21 consecutive days to complete a 21-day cycle.	Navitoclax 21/21 Day Cycle: 200 mg n=4 Participants Navitoclax 200 mg administered for 21 consecutive days to complete a 21-day cycle.	Navitoclax 21/21 Day Cycle: 250 mg n=3 Participants Navitoclax 250 mg administered for 21 consecutive days to complete a 21-day cycle.	Navitoclax 21/21 Day Cycle: 300 mg n=4 Participants Navitoclax 300 mg administered for 21 consecutive days to complete a 21-day cycle.	Phase 2: Navitoclax 100 mg n=4 Participants Navitoclax 100 mg in participants with CLL who had relapsed following any (but no more than 5) prior myelosuppressive/chemotherapy treatment regimen(s).	Phase 2: Navitoclax 250 mg n=27 Participants Navitoclax 250 mg in participants with CLL who had relapsed following any (but no more than 5) prior myelosuppressive/chemotherapy treatment regimen(s).	Total n=60 Participants Total of all reporting groups
Age, Customized < 65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	3 Participants n=8 Participants	0 Participants n=8 Participants	1 Participants n=24 Participants	1 Participants n=42 Participants	10 Participants n=42 Participants	19 Participants n=42 Participants
Age, Customized >= 65 years	2 Participants n=5 Participants	6 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants	1 Participants n=8 Participants	3 Participants n=8 Participants	3 Participants n=24 Participants	3 Participants n=42 Participants	17 Participants n=42 Participants	41 Participants n=42 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants	1 Participants n=8 Participants	0 Participants n=8 Participants	3 Participants n=24 Participants	0 Participants n=42 Participants	8 Participants n=42 Participants	18 Participants n=42 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	5 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	3 Participants n=8 Participants	3 Participants n=8 Participants	1 Participants n=24 Participants	4 Participants n=42 Participants	19 Participants n=42 Participants	42 Participants n=42 Participants
Race/Ethnicity, Customized White	3 Participants n=5 Participants	6 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	2 Participants n=21 Participants	3 Participants n=8 Participants	2 Participants n=8 Participants	3 Participants n=24 Participants	4 Participants n=42 Participants	24 Participants n=42 Participants	52 Participants n=42 Participants
Race/Ethnicity, Customized Black	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	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	1 Participants n=42 Participants
Race/Ethnicity, Customized American Indian/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	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race/Ethnicity, Customized Native Hawaiian or 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	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race/Ethnicity, Customized 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	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	1 Participants n=42 Participants
Race/Ethnicity, Customized Mixed	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants
Race/Ethnicity, Customized Other, Not Specified	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants	1 Participants n=24 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	5 Participants n=42 Participants
Race/Ethnicity, Customized Missing	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	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race/Ethnicity, Customized Hispanic	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	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race/Ethnicity, Customized No Ethnicity	3 Participants n=5 Participants	6 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	4 Participants n=8 Participants	3 Participants n=8 Participants	4 Participants n=24 Participants	4 Participants n=42 Participants	27 Participants n=42 Participants	60 Participants n=42 Participants

PRIMARY outcome

Timeframe: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles.

Outcome measures

Outcome measures
Measure	Navitoclax 14/21 Day Cycle: 10 mg n=3 Participants Navitoclax 10 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.	Navitoclax 14/21 Day Cycle: 110 mg n=6 Participants Navitoclax 110 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.	Navitoclax 14/21 Day Cycle: 200 mg n=3 Participants Navitoclax 200 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.	Navitoclax 14/21 Day Cycle: 250 mg n=3 Participants Navitoclax 250 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.	Navitoclax 21/21 Day Cycle: 125 mg n=3 Participants Navitoclax 125 mg administered for 21 consecutive days to complete a 21-day cycle.	Navitoclax 21/21 Day Cycle: 200 mg n=4 Participants Navitoclax 200 mg administered for 21 consecutive days to complete a 21-day cycle.	Navitoclax 21/21 Day Cycle: 250 mg n=3 Participants Navitoclax 250 mg administered for 21 consecutive days to complete a 21-day cycle.	Navitoclax 21/21 Day Cycle: 300 mg n=4 Participants Navitoclax 300 mg administered for 21 consecutive days to complete a 21-day cycle.
Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations Due to Adverse Events (AEs) Any AE	3 Participants	6 Participants	3 Participants	3 Participants	3 Participants	4 Participants	3 Participants	4 Participants
Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations Due to Adverse Events (AEs) Any AE at least possibly related to navitoclax	3 Participants	4 Participants	3 Participants	3 Participants	3 Participants	4 Participants	3 Participants	4 Participants
Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations Due to Adverse Events (AEs) Any AE with NCI CTCAE Grade ≥ 3	2 Participants	4 Participants	3 Participants	2 Participants	2 Participants	4 Participants	3 Participants	4 Participants
Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations Due to Adverse Events (AEs) Any AE with NCI CTCAE Grade 3 or 4	2 Participants	4 Participants	3 Participants	2 Participants	2 Participants	4 Participants	3 Participants	4 Participants
Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations Due to Adverse Events (AEs) Any SAE	2 Participants	4 Participants	2 Participants	2 Participants	2 Participants	4 Participants	2 Participants	3 Participants
Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations Due to Adverse Events (AEs) Any AE leading to navitoclax discontinuation	1 Participants	2 Participants	0 Participants	1 Participants	2 Participants	1 Participants	2 Participants	1 Participants
Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations Due to Adverse Events (AEs) Any AE leading to navitoclax dose reduction	0 Participants	1 Participants	1 Participants	2 Participants	0 Participants	1 Participants	2 Participants	0 Participants
Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations Due to Adverse Events (AEs) Any AE leading to navitoclax interruption	0 Participants	4 Participants	3 Participants	2 Participants	1 Participants	4 Participants	3 Participants	4 Participants
Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations Due to Adverse Events (AEs) Any AE leading to dose delay	2 Participants	3 Participants	1 Participants	2 Participants	0 Participants	0 Participants	0 Participants	2 Participants
Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations Due to Adverse Events (AEs) Any dose limiting toxicity (DLT)	0 Participants	2 Participants	0 Participants	2 Participants	0 Participants	2 Participants	2 Participants	2 Participants
Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations Due to Adverse Events (AEs) Any fatal AE	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations Due to Adverse Events (AEs) Deaths	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Cycle 1 (Up to 21 days) plus 7 days

DLTs were graded according to NCI CTCAE version 3.0 (grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=life threatening; grade 5=death). Any of the following events, considered possibly or probably related to the administration of navitoclax, were considered a DLT: Grade 4 thrombocytopenia (\< 25,000/mm\^3); platelet counts \< 25,000/mm\^3, Grade 2 or higher bleeding associated with thrombocytopenia; all other Grade 3, 4 or 5 adverse events were considered a DLT. Exceptions included: Grade 3, 4 febrile neutropenia less than 7 days; Grade 3, 4 leukopenia; Grade 3, 4 lymphopenia; Grade 3 nausea, vomiting and/or diarrhea unless unresponsive to treatment; Grade 2 toxicity that requires dose modification or delay of \> 1 week.

Outcome measures

Outcome measures
Measure	Navitoclax 14/21 Day Cycle: 10 mg n=3 Participants Navitoclax 10 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.	Navitoclax 14/21 Day Cycle: 110 mg n=6 Participants Navitoclax 110 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.	Navitoclax 14/21 Day Cycle: 200 mg n=3 Participants Navitoclax 200 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.	Navitoclax 14/21 Day Cycle: 250 mg n=3 Participants Navitoclax 250 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.	Navitoclax 21/21 Day Cycle: 125 mg n=3 Participants Navitoclax 125 mg administered for 21 consecutive days to complete a 21-day cycle.	Navitoclax 21/21 Day Cycle: 200 mg n=4 Participants Navitoclax 200 mg administered for 21 consecutive days to complete a 21-day cycle.	Navitoclax 21/21 Day Cycle: 250 mg n=3 Participants Navitoclax 250 mg administered for 21 consecutive days to complete a 21-day cycle.	Navitoclax 21/21 Day Cycle: 300 mg n=4 Participants Navitoclax 300 mg administered for 21 consecutive days to complete a 21-day cycle.
Phase 1: Number of Participants With DLTs in the Dose Escalation Phase	0 Participants	1 Participants	0 Participants	2 Participants	0 Participants	1 Participants	1 Participants	1 Participants

PRIMARY outcome

Timeframe: Cycle 1 (Up to 21 days) plus 7 days

The MTD was defined as the dose at which 30% of participants experienced a DLT during the first cycle. DLTs were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 (grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=life threatening; grade 5=death). Any of the following events, considered possibly or probably related to the administration of navitoclax, were considered a DLT: Grade 4 thrombocytopenia (\< 25,000/mm\^3); platelet counts \< 25,000/mm\^3, Grade 2 or higher bleeding associated with thrombocytopenia; all other Grade 3, 4 or 5 adverse events were considered a DLT. Exceptions included: Grade 3, 4 febrile neutropenia less than 7 days; Grade 3, 4 leukopenia; Grade 3, 4 lymphopenia; Grade 3 nausea, vomiting and/or diarrhea unless unresponsive to treatment; Grade 2 toxicity that requires dose modification or delay of \> 1 week.

Outcome measures

Outcome measures
Measure	Navitoclax 14/21 Day Cycle: 10 mg n=15 Participants Navitoclax 10 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.	Navitoclax 14/21 Day Cycle: 110 mg n=14 Participants Navitoclax 110 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.	Navitoclax 14/21 Day Cycle: 200 mg Navitoclax 200 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.	Navitoclax 14/21 Day Cycle: 250 mg Navitoclax 250 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.	Navitoclax 21/21 Day Cycle: 125 mg Navitoclax 125 mg administered for 21 consecutive days to complete a 21-day cycle.	Navitoclax 21/21 Day Cycle: 200 mg Navitoclax 200 mg administered for 21 consecutive days to complete a 21-day cycle.	Navitoclax 21/21 Day Cycle: 250 mg Navitoclax 250 mg administered for 21 consecutive days to complete a 21-day cycle.	Navitoclax 21/21 Day Cycle: 300 mg Navitoclax 300 mg administered for 21 consecutive days to complete a 21-day cycle.
Phase 1: Maximum Tolerated Dose (MTD) in the Dose Escalation Phase	200 mg	250 mg	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Cycle 1 (Up to 21 days) plus 7 days

The RPTD was determined based on observed DLTs and/or determination of the MTD in phase 1. (See Outcome Measures 2 and 3 above for definition of DLT and MTD.)

Outcome measures

Outcome measures
Measure	Navitoclax 14/21 Day Cycle: 10 mg n=15 Participants Navitoclax 10 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.	Navitoclax 14/21 Day Cycle: 110 mg n=14 Participants Navitoclax 110 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.	Navitoclax 14/21 Day Cycle: 200 mg Navitoclax 200 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.	Navitoclax 14/21 Day Cycle: 250 mg Navitoclax 250 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.	Navitoclax 21/21 Day Cycle: 125 mg Navitoclax 125 mg administered for 21 consecutive days to complete a 21-day cycle.	Navitoclax 21/21 Day Cycle: 200 mg Navitoclax 200 mg administered for 21 consecutive days to complete a 21-day cycle.	Navitoclax 21/21 Day Cycle: 250 mg Navitoclax 250 mg administered for 21 consecutive days to complete a 21-day cycle.	Navitoclax 21/21 Day Cycle: 300 mg Navitoclax 300 mg administered for 21 consecutive days to complete a 21-day cycle.
Phase 1: Recommended Phase 2 Dose (RPTD) Determined in the Dose Escalation Phase	250 mg	250 mg	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Cycle 1 Days 1 and 14: pre-dose, 2, 4, 6, 8 hours post-dose

Population: Participants with an assessment at given time point. One participant in the Navitoclax 14/21 Day Cycle: 250 mg arm dose-reduced to 200 mg on Days 4 to14, and therefore was analyzed in the Navitoclax 14/21 Day Cycle: 200 mg arm for Cycle 1 Day 14.

Outcome measures

Outcome measures
Measure	Navitoclax 14/21 Day Cycle: 10 mg n=3 Participants Navitoclax 10 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.	Navitoclax 14/21 Day Cycle: 110 mg n=6 Participants Navitoclax 110 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.	Navitoclax 14/21 Day Cycle: 200 mg n=4 Participants Navitoclax 200 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.	Navitoclax 14/21 Day Cycle: 250 mg n=3 Participants Navitoclax 250 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.	Navitoclax 21/21 Day Cycle: 125 mg n=3 Participants Navitoclax 125 mg administered for 21 consecutive days to complete a 21-day cycle.	Navitoclax 21/21 Day Cycle: 200 mg n=4 Participants Navitoclax 200 mg administered for 21 consecutive days to complete a 21-day cycle.	Navitoclax 21/21 Day Cycle: 250 mg n=3 Participants Navitoclax 250 mg administered for 21 consecutive days to complete a 21-day cycle.	Navitoclax 21/21 Day Cycle: 300 mg n=4 Participants Navitoclax 300 mg administered for 21 consecutive days to complete a 21-day cycle.
Phase 1: Time to Maximum Observed Plasma Concentration (Tmax) of Navitoclax Cycle 1 Day 1	6.0 hours Standard Deviation 2.0	5.9 hours Standard Deviation 1.6	6.7 hours Standard Deviation 1.2	7.3 hours Standard Deviation 1.2	7.3 hours Standard Deviation 1.2	6.5 hours Standard Deviation 1.0	6.7 hours Standard Deviation 2.3	7.5 hours Standard Deviation 1.0
Phase 1: Time to Maximum Observed Plasma Concentration (Tmax) of Navitoclax Cycle 1 Day 14	4.3 hours Standard Deviation 1.5	3.5 hours Standard Deviation 2.8	6.8 hours Standard Deviation 1.5	5.7 hours Standard Deviation 0.4	5.8 hours Standard Deviation 1.8	6.7 hours Standard Deviation 1.2	6.9 hours Standard Deviation 1.8	7.3 hours Standard Deviation 1.2

PRIMARY outcome

Timeframe: Cycle 1 Days 1 and 14: pre-dose, 2, 4, 6, 8 hours post-dose

Outcome measures

Outcome measures
Measure	Navitoclax 14/21 Day Cycle: 10 mg n=3 Participants Navitoclax 10 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.	Navitoclax 14/21 Day Cycle: 110 mg n=6 Participants Navitoclax 110 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.	Navitoclax 14/21 Day Cycle: 200 mg n=4 Participants Navitoclax 200 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.	Navitoclax 14/21 Day Cycle: 250 mg n=3 Participants Navitoclax 250 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.	Navitoclax 21/21 Day Cycle: 125 mg n=3 Participants Navitoclax 125 mg administered for 21 consecutive days to complete a 21-day cycle.	Navitoclax 21/21 Day Cycle: 200 mg n=4 Participants Navitoclax 200 mg administered for 21 consecutive days to complete a 21-day cycle.	Navitoclax 21/21 Day Cycle: 250 mg n=3 Participants Navitoclax 250 mg administered for 21 consecutive days to complete a 21-day cycle.	Navitoclax 21/21 Day Cycle: 300 mg n=4 Participants Navitoclax 300 mg administered for 21 consecutive days to complete a 21-day cycle.
Phase 1: Maximum Observed Plasma Concentration (Cmax) Cycle 1 Day 1	0.25 μg/mL Standard Deviation 0.14	1.19 μg/mL Standard Deviation 0.37	2.60 μg/mL Standard Deviation 1.54	5.19 μg/mL Standard Deviation 2.70	2.24 μg/mL Standard Deviation 0.98	2.73 μg/mL Standard Deviation 0.82	2.59 μg/mL Standard Deviation 1.60	3.30 μg/mL Standard Deviation 1.20
Phase 1: Maximum Observed Plasma Concentration (Cmax) Cycle 1 Day 14	0.42 μg/mL Standard Deviation 0.17	1.87 μg/mL Standard Deviation 0.71	4.44 μg/mL Standard Deviation 3.59	3.21 μg/mL Standard Deviation 0.12	2.68 μg/mL Standard Deviation 1.11	3.46 μg/mL Standard Deviation 1.57	3.74 μg/mL Standard Deviation 1.19	3.11 μg/mL Standard Deviation 2.26

PRIMARY outcome

Timeframe: Cycle 1 Days 1 and 14: pre-dose, 2, 4, 6, 8 hours post-dose

Outcome measures

Outcome measures
Measure	Navitoclax 14/21 Day Cycle: 10 mg n=3 Participants Navitoclax 10 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.	Navitoclax 14/21 Day Cycle: 110 mg n=6 Participants Navitoclax 110 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.	Navitoclax 14/21 Day Cycle: 200 mg n=4 Participants Navitoclax 200 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.	Navitoclax 14/21 Day Cycle: 250 mg n=3 Participants Navitoclax 250 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.	Navitoclax 21/21 Day Cycle: 125 mg n=3 Participants Navitoclax 125 mg administered for 21 consecutive days to complete a 21-day cycle.	Navitoclax 21/21 Day Cycle: 200 mg n=4 Participants Navitoclax 200 mg administered for 21 consecutive days to complete a 21-day cycle.	Navitoclax 21/21 Day Cycle: 250 mg n=3 Participants Navitoclax 250 mg administered for 21 consecutive days to complete a 21-day cycle.	Navitoclax 21/21 Day Cycle: 300 mg n=4 Participants Navitoclax 300 mg administered for 21 consecutive days to complete a 21-day cycle.
Phase 1: Area Under the Plasma Concentration-Time Curve From Time 0 to Hour 8 (AUC8) Cycle 1 Day 1	1.0 μg•hr/mL Standard Deviation 0.65	5.7 μg•hr/mL Standard Deviation 2.7	10.6 μg•hr/mL Standard Deviation 4.0	19.8 μg•hr/mL Standard Deviation 14.0	12.0 μg•hr/mL Standard Deviation 4.2	12.3 μg•hr/mL Standard Deviation 3.0	12.0 μg•hr/mL Standard Deviation 9.2	14.3 μg•hr/mL Standard Deviation 5.7
Phase 1: Area Under the Plasma Concentration-Time Curve From Time 0 to Hour 8 (AUC8) Cycle 1 Day 14	2.2 μg•hr/mL Standard Deviation 0.95	11.1 μg•hr/mL Standard Deviation 2.7	24.2 μg•hr/mL Standard Deviation 18.1	17.8 μg•hr/mL Standard Deviation 2.3	15.7 μg•hr/mL Standard Deviation 6.8	18.4 μg•hr/mL Standard Deviation 8.7	24.4 μg•hr/mL Standard Deviation 5.7	21.6 μg•hr/mL Standard Deviation 15.6

PRIMARY outcome

Timeframe: Cycle 1 Day 1: pre-dose, 2, 4, 6, 8, and 24 hours post-dose; Cycle 1 Days 14: pre-dose, 2, 4, 6, 8

The AUC24 was derived and reported from Cycle 1 Day 1 values and Cycle 1 Day 14 values; the pre-dose value taken on Day 14 was utilized as 24-hour timepoint on Day 14 to generate AUC24 for Day 14.

Outcome measures

Outcome measures
Measure	Navitoclax 14/21 Day Cycle: 10 mg n=3 Participants Navitoclax 10 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.	Navitoclax 14/21 Day Cycle: 110 mg n=6 Participants Navitoclax 110 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.	Navitoclax 14/21 Day Cycle: 200 mg n=4 Participants Navitoclax 200 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.	Navitoclax 14/21 Day Cycle: 250 mg n=3 Participants Navitoclax 250 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.	Navitoclax 21/21 Day Cycle: 125 mg n=3 Participants Navitoclax 125 mg administered for 21 consecutive days to complete a 21-day cycle.	Navitoclax 21/21 Day Cycle: 200 mg n=4 Participants Navitoclax 200 mg administered for 21 consecutive days to complete a 21-day cycle.	Navitoclax 21/21 Day Cycle: 250 mg n=3 Participants Navitoclax 250 mg administered for 21 consecutive days to complete a 21-day cycle.	Navitoclax 21/21 Day Cycle: 300 mg n=4 Participants Navitoclax 300 mg administered for 21 consecutive days to complete a 21-day cycle.
Phase 1: Area Under the Plasma Concentration-Time Curve From Time 0 to Hour 24 (AUC24) Cycle 1 Day 1	2.7 μg•hr/mL Standard Deviation 1.0	15.0 μg•hr/mL Standard Deviation 3.2	34.0 μg•hr/mL Standard Deviation 13.8	67.8 μg•hr/mL Standard Deviation 27.7	37.5 μg•hr/mL Standard Deviation 16.0	44.0 μg•hr/mL Standard Deviation 18.7	49.5 μg•hr/mL Standard Deviation 12.3	52.9 μg•hr/mL Standard Deviation 20.1
Phase 1: Area Under the Plasma Concentration-Time Curve From Time 0 to Hour 24 (AUC24) Cycle 1 Day 14	5.5 μg•hr/mL Standard Deviation 2.7	30.9 μg•hr/mL Standard Deviation 7.7	68.7 μg•hr/mL Standard Deviation 42.9	50.6 μg•hr/mL Standard Deviation 0.36	43.5 μg•hr/mL Standard Deviation 16.6	56.2 μg•hr/mL Standard Deviation 28.6	72.7 μg•hr/mL Standard Deviation 14.4	64.8 μg•hr/mL Standard Deviation 49.4

PRIMARY outcome

Timeframe: Cycle 1 Days 1 and 14: pre-dose, 2, 4, 6, 8 hours post-dose

Outcome measures

Outcome measures
Measure	Navitoclax 14/21 Day Cycle: 10 mg n=3 Participants Navitoclax 10 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.	Navitoclax 14/21 Day Cycle: 110 mg n=6 Participants Navitoclax 110 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.	Navitoclax 14/21 Day Cycle: 200 mg n=4 Participants Navitoclax 200 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.	Navitoclax 14/21 Day Cycle: 250 mg n=3 Participants Navitoclax 250 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.	Navitoclax 21/21 Day Cycle: 125 mg n=3 Participants Navitoclax 125 mg administered for 21 consecutive days to complete a 21-day cycle.	Navitoclax 21/21 Day Cycle: 200 mg n=4 Participants Navitoclax 200 mg administered for 21 consecutive days to complete a 21-day cycle.	Navitoclax 21/21 Day Cycle: 250 mg n=3 Participants Navitoclax 250 mg administered for 21 consecutive days to complete a 21-day cycle.	Navitoclax 21/21 Day Cycle: 300 mg n=4 Participants Navitoclax 300 mg administered for 21 consecutive days to complete a 21-day cycle.
Phase 1: Cmax/Dose Cycle 1 Day 1	24.5 ng/mL/mg Standard Deviation 13.9	10.7 ng/mL/mg Standard Deviation 3.4	13.0 ng/mL/mg Standard Deviation 7.7	20.8 ng/mL/mg Standard Deviation 10.8	17.9 ng/mL/mg Standard Deviation 7.9	13.7 ng/mL/mg Standard Deviation 4.1	10.4 ng/mL/mg Standard Deviation 6.4	11.0 ng/mL/mg Standard Deviation 4.0
Phase 1: Cmax/Dose Cycle 1 Day 14	42.3 ng/mL/mg Standard Deviation 16.6	17.0 ng/mL/mg Standard Deviation 6.4	22.2 ng/mL/mg Standard Deviation 17.9	12.8 ng/mL/mg Standard Deviation 0.48	21.4 ng/mL/mg Standard Deviation 8.9	17.3 ng/mL/mg Standard Deviation 7.9	15.0 ng/mL/mg Standard Deviation 4.8	10.4 ng/mL/mg Standard Deviation 7.5

PRIMARY outcome

Timeframe: Cycle 1 Days 1 and 14: pre-dose, 2, 4, 6, 8 hours post-dose

Outcome measures

Outcome measures
Measure	Navitoclax 14/21 Day Cycle: 10 mg n=3 Participants Navitoclax 10 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.	Navitoclax 14/21 Day Cycle: 110 mg n=6 Participants Navitoclax 110 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.	Navitoclax 14/21 Day Cycle: 200 mg n=4 Participants Navitoclax 200 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.	Navitoclax 14/21 Day Cycle: 250 mg n=3 Participants Navitoclax 250 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.	Navitoclax 21/21 Day Cycle: 125 mg n=3 Participants Navitoclax 125 mg administered for 21 consecutive days to complete a 21-day cycle.	Navitoclax 21/21 Day Cycle: 200 mg n=4 Participants Navitoclax 200 mg administered for 21 consecutive days to complete a 21-day cycle.	Navitoclax 21/21 Day Cycle: 250 mg n=3 Participants Navitoclax 250 mg administered for 21 consecutive days to complete a 21-day cycle.	Navitoclax 21/21 Day Cycle: 300 mg n=4 Participants Navitoclax 300 mg administered for 21 consecutive days to complete a 21-day cycle.
Phase 1: AUC8/Dose Cycle 1 Day 1	99.9 ng•hr/mL/mg Standard Deviation 65.0	52.0 ng•hr/mL/mg Standard Deviation 24.7	53.1 ng•hr/mL/mg Standard Deviation 20.1	79.2 ng•hr/mL/mg Standard Deviation 56.1	95.8 ng•hr/mL/mg Standard Deviation 33.5	61.3 ng•hr/mL/mg Standard Deviation 14.9	47.9 ng•hr/mL/mg Standard Deviation 36.8	47.6 ng•hr/mL/mg Standard Deviation 18.8
Phase 1: AUC8/Dose Cycle 1 Day 14	215.0 ng•hr/mL/mg Standard Deviation 95.1	101.0 ng•hr/mL/mg Standard Deviation 24.7	121.0 ng•hr/mL/mg Standard Deviation 90.4	71.3 ng•hr/mL/mg Standard Deviation 9.1	125.0 ng•hr/mL/mg Standard Deviation 54.1	92.1 ng•hr/mL/mg Standard Deviation 43.3	97.7 ng•hr/mL/mg Standard Deviation 22.6	72.0 ng•hr/mL/mg Standard Deviation 51.9

PRIMARY outcome

Timeframe: Cycle 1 Day 1: pre-dose, 2, 4, 6, 8, and 24 hours post-dose; Cycle 1 Days 14: pre-dose, 2, 4, 6, 8

The AUC24 was derived and reported from Cycle 1 Day 1 values and Cycle 1 Day 14 values; the pre-dose value taken on Day 14 was utilized as 24-hour timepoint on Day 14 to generate AUC24 for Day 14.

Outcome measures

Outcome measures
Measure	Navitoclax 14/21 Day Cycle: 10 mg n=3 Participants Navitoclax 10 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.	Navitoclax 14/21 Day Cycle: 110 mg n=6 Participants Navitoclax 110 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.	Navitoclax 14/21 Day Cycle: 200 mg n=4 Participants Navitoclax 200 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.	Navitoclax 14/21 Day Cycle: 250 mg n=3 Participants Navitoclax 250 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.	Navitoclax 21/21 Day Cycle: 125 mg n=3 Participants Navitoclax 125 mg administered for 21 consecutive days to complete a 21-day cycle.	Navitoclax 21/21 Day Cycle: 200 mg n=4 Participants Navitoclax 200 mg administered for 21 consecutive days to complete a 21-day cycle.	Navitoclax 21/21 Day Cycle: 250 mg n=3 Participants Navitoclax 250 mg administered for 21 consecutive days to complete a 21-day cycle.	Navitoclax 21/21 Day Cycle: 300 mg n=4 Participants Navitoclax 300 mg administered for 21 consecutive days to complete a 21-day cycle.
Phase 1: AUC24/Dose Cycle 1 Day 1	268 ng•hr/mL/mg Standard Deviation 100.0	136 ng•hr/mL/mg Standard Deviation 28.8	170 ng•hr/mL/mg Standard Deviation 69.2	271 ng•hr/mL/mg Standard Deviation 111.0	300 ng•hr/mL/mg Standard Deviation 128.0	220 ng•hr/mL/mg Standard Deviation 93.6	198 ng•hr/mL/mg Standard Deviation 49.3	176 ng•hr/mL/mg Standard Deviation 67.0
Phase 1: AUC24/Dose Cycle 1 Day 14	546 ng•hr/mL/mg Standard Deviation 267.0	281 ng•hr/mL/mg Standard Deviation 69.9	344 ng•hr/mL/mg Standard Deviation 215.0	202 ng•hr/mL/mg Standard Deviation 1.5	348 ng•hr/mL/mg Standard Deviation 133.0	281 ng•hr/mL/mg Standard Deviation 143.0	291 ng•hr/mL/mg Standard Deviation 57.5	216.0 ng•hr/mL/mg Standard Deviation 165.0

PRIMARY outcome

Timeframe: Cycle 1 Day 1: pre-dose, 2, 4, 6, 8 hours post-dose

Population: Participants with an assessment.

Outcome measures

Outcome measures
Measure	Navitoclax 14/21 Day Cycle: 10 mg n=2 Participants Navitoclax 10 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.	Navitoclax 14/21 Day Cycle: 110 mg n=3 Participants Navitoclax 110 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.	Navitoclax 14/21 Day Cycle: 200 mg n=2 Participants Navitoclax 200 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.	Navitoclax 14/21 Day Cycle: 250 mg n=1 Participants Navitoclax 250 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.	Navitoclax 21/21 Day Cycle: 125 mg Navitoclax 125 mg administered for 21 consecutive days to complete a 21-day cycle.	Navitoclax 21/21 Day Cycle: 200 mg n=3 Participants Navitoclax 200 mg administered for 21 consecutive days to complete a 21-day cycle.	Navitoclax 21/21 Day Cycle: 250 mg Navitoclax 250 mg administered for 21 consecutive days to complete a 21-day cycle.	Navitoclax 21/21 Day Cycle: 300 mg n=1 Participants Navitoclax 300 mg administered for 21 consecutive days to complete a 21-day cycle.
Phase 1: Terminal Phase Elimination Rate Constant (β) for Navitoclax	0.072 1/H Standard Deviation 0.029	0.077 1/H Standard Deviation 0.006	0.067 1/H Standard Deviation 0.030	0.059 1/H Standard Deviation NA not applicable (1 participant analyzed)	—	0.066 1/H Standard Deviation 0.025	—	0.039 1/H Standard Deviation NA not applicable (1 participant analyzed)

PRIMARY outcome

Timeframe: Cycle 1 Day 1: pre-dose, 2, 4, 6, 8 hours post-dose

Population: Participants with an assessment.

For t1/2, the harmonic mean and psuedo-standard deviation are used.

Outcome measures

Outcome measures
Measure	Navitoclax 14/21 Day Cycle: 10 mg n=2 Participants Navitoclax 10 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.	Navitoclax 14/21 Day Cycle: 110 mg n=3 Participants Navitoclax 110 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.	Navitoclax 14/21 Day Cycle: 200 mg n=2 Participants Navitoclax 200 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.	Navitoclax 14/21 Day Cycle: 250 mg n=1 Participants Navitoclax 250 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.	Navitoclax 21/21 Day Cycle: 125 mg Navitoclax 125 mg administered for 21 consecutive days to complete a 21-day cycle.	Navitoclax 21/21 Day Cycle: 200 mg n=3 Participants Navitoclax 200 mg administered for 21 consecutive days to complete a 21-day cycle.	Navitoclax 21/21 Day Cycle: 250 mg Navitoclax 250 mg administered for 21 consecutive days to complete a 21-day cycle.	Navitoclax 21/21 Day Cycle: 300 mg n=1 Participants Navitoclax 300 mg administered for 21 consecutive days to complete a 21-day cycle.
Phase 1: Terminal Phase Elimination Half-life (t1/2) of Navitoclax	9.62 hours Standard Deviation 4.18	8.99 hours Standard Deviation 0.66	10.41 hours Standard Deviation 5.21	11.72 hours Standard Deviation NA Not applicable (1 participant analyzed)	—	10.51 hours Standard Deviation 4.01	—	17.88 hours Standard Deviation NA Not applicable (1 participant analyzed)

PRIMARY outcome

Timeframe: From first dose of study drug to 30 days post-last dose. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles.

Outcome measures

Outcome measures
Measure	Navitoclax 14/21 Day Cycle: 10 mg n=4 Participants Navitoclax 10 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.	Navitoclax 14/21 Day Cycle: 110 mg n=27 Participants Navitoclax 110 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.	Navitoclax 14/21 Day Cycle: 200 mg Navitoclax 200 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.	Navitoclax 14/21 Day Cycle: 250 mg Navitoclax 250 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.	Navitoclax 21/21 Day Cycle: 125 mg Navitoclax 125 mg administered for 21 consecutive days to complete a 21-day cycle.	Navitoclax 21/21 Day Cycle: 200 mg Navitoclax 200 mg administered for 21 consecutive days to complete a 21-day cycle.	Navitoclax 21/21 Day Cycle: 250 mg Navitoclax 250 mg administered for 21 consecutive days to complete a 21-day cycle.	Navitoclax 21/21 Day Cycle: 300 mg Navitoclax 300 mg administered for 21 consecutive days to complete a 21-day cycle.
Phase 2: Number of Participants With TEAEs, SAEs, and Discontinuations Due to AEs Any AE	4 Participants	27 Participants	—	—	—	—	—	—
Phase 2: Number of Participants With TEAEs, SAEs, and Discontinuations Due to AEs Any AE at least possibly related to navitoclax	4 Participants	26 Participants	—	—	—	—	—	—
Phase 2: Number of Participants With TEAEs, SAEs, and Discontinuations Due to AEs Any AE with NCI CTCAE Grade ≥ 3	3 Participants	23 Participants	—	—	—	—	—	—
Phase 2: Number of Participants With TEAEs, SAEs, and Discontinuations Due to AEs Any AE with NCI CTCAE Grade 3 or 4	3 Participants	23 Participants	—	—	—	—	—	—
Phase 2: Number of Participants With TEAEs, SAEs, and Discontinuations Due to AEs Any SAE	1 Participants	12 Participants	—	—	—	—	—	—
Phase 2: Number of Participants With TEAEs, SAEs, and Discontinuations Due to AEs Any AE leading to navitoclax discontinuation	1 Participants	9 Participants	—	—	—	—	—	—
Phase 2: Number of Participants With TEAEs, SAEs, and Discontinuations Due to AEs Any AE leading to navitoclax dose reduction	1 Participants	10 Participants	—	—	—	—	—	—
Phase 2: Number of Participants With TEAEs, SAEs, and Discontinuations Due to AEs Any AE leading to navitoclax interruption	2 Participants	16 Participants	—	—	—	—	—	—
Phase 2: Number of Participants With TEAEs, SAEs, and Discontinuations Due to AEs Any AE leading to navitoclax dose delay	2 Participants	5 Participants	—	—	—	—	—	—
Phase 2: Number of Participants With TEAEs, SAEs, and Discontinuations Due to AEs Any fatal AE	0 Participants	1 Participants	—	—	—	—	—	—
Phase 2: Number of Participants With TEAEs, SAEs, and Discontinuations Due to AEs Deaths	1 Participants	8 Participants	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Cycle 1 Day 1: 4-8 h postdose; Cycle 1 Day 15: predose; Cycle 3 Day 1: predose, 4-8 h postdose; Cycle 5 Day 1: predose, 4-8 h postdose; Cycle 7 Day 1: predose, 4-8 h postdose; Cycle 9 Day 1: predose, 4-8 h postdose

Population: Participants with an assessment at given time point. It was pre-specified in the statistical analysis plans to analyze the dose-normalized assessments in phase 2 navitoclax arms combined.

Outcome measures

Outcome measures
Measure	Navitoclax 14/21 Day Cycle: 10 mg n=31 Participants Navitoclax 10 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.	Navitoclax 14/21 Day Cycle: 110 mg Navitoclax 110 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.	Navitoclax 14/21 Day Cycle: 200 mg Navitoclax 200 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.	Navitoclax 14/21 Day Cycle: 250 mg Navitoclax 250 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.	Navitoclax 21/21 Day Cycle: 125 mg Navitoclax 125 mg administered for 21 consecutive days to complete a 21-day cycle.	Navitoclax 21/21 Day Cycle: 200 mg Navitoclax 200 mg administered for 21 consecutive days to complete a 21-day cycle.	Navitoclax 21/21 Day Cycle: 250 mg Navitoclax 250 mg administered for 21 consecutive days to complete a 21-day cycle.	Navitoclax 21/21 Day Cycle: 300 mg Navitoclax 300 mg administered for 21 consecutive days to complete a 21-day cycle.
Phase 2: Dose-Normalized Plasma Concentrations After Navitoclax Once Daily Dosing Cycle 7 Day 1: 4-8 h postdose	15.9 (ng/mL)/mg Standard Deviation 9.14	—	—	—	—	—	—	—
Phase 2: Dose-Normalized Plasma Concentrations After Navitoclax Once Daily Dosing Cycle 9 Day 1: predose	11.4 (ng/mL)/mg Standard Deviation 9.68	—	—	—	—	—	—	—
Phase 2: Dose-Normalized Plasma Concentrations After Navitoclax Once Daily Dosing Cycle 9 Day 1: 4-8 h postdose	13.5 (ng/mL)/mg Standard Deviation 6.41	—	—	—	—	—	—	—
Phase 2: Dose-Normalized Plasma Concentrations After Navitoclax Once Daily Dosing Cycle 1 Day 1: 4-8 h postdose	9.49 (ng/mL)/mg Standard Deviation 4.80	—	—	—	—	—	—	—
Phase 2: Dose-Normalized Plasma Concentrations After Navitoclax Once Daily Dosing Cycle 1 Day 15: predose	9.64 (ng/mL)/mg Standard Deviation 5.85	—	—	—	—	—	—	—
Phase 2: Dose-Normalized Plasma Concentrations After Navitoclax Once Daily Dosing Cycle 3 Day 1: predose	9.84 (ng/mL)/mg Standard Deviation 3.55	—	—	—	—	—	—	—
Phase 2: Dose-Normalized Plasma Concentrations After Navitoclax Once Daily Dosing Cycle 3 Day 1: 4-8 h postdose	15.2 (ng/mL)/mg Standard Deviation 8.04	—	—	—	—	—	—	—
Phase 2: Dose-Normalized Plasma Concentrations After Navitoclax Once Daily Dosing Cycle 5 Day 1: predose	9.84 (ng/mL)/mg Standard Deviation 4.38	—	—	—	—	—	—	—
Phase 2: Dose-Normalized Plasma Concentrations After Navitoclax Once Daily Dosing Cycle 5 Day 1: 4-8 h postdose	15.7 (ng/mL)/mg Standard Deviation 8.28	—	—	—	—	—	—	—
Phase 2: Dose-Normalized Plasma Concentrations After Navitoclax Once Daily Dosing Cycle 7 Day 1: predose	10.4 (ng/mL)/mg Standard Deviation 5.26	—	—	—	—	—	—	—

Deaths: 8 deaths

Serious adverse events

Serious adverse events
Measure	Navitoclax 14/21 Day Cycle: 10 mg n=3 participants at risk Navitoclax 10 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21- day cycle.	Navitoclax 14/21 Day Cycle: 110 mg n=6 participants at risk Navitoclax 110 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21- day cycle.	Navitoclax 14/21 Day Cycle: 200 mg n=3 participants at risk Navitoclax 200 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21- day cycle.	Navitoclax 14/21 Day Cycle: 250 mg n=3 participants at risk Navitoclax 250 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21- day cycle.	Navitoclax 21/21 Day Cycle: 125 mg n=3 participants at risk Navitoclax 125 mg administered for 21 consecutive days to complete a 21-day cycle.	Navitoclax 21/21 Day Cycle: 200 mg n=4 participants at risk Navitoclax 200 mg administered for 21 consecutive days to complete a 21-day cycle.	Navitoclax 21/21 Day Cycle: 250 mg n=3 participants at risk Navitoclax 250 mg administered for 21 consecutive days to complete a 21-day cycle.	Navitoclax 21/21 Day Cycle: 300 mg n=4 participants at risk Navitoclax 300 mg administered for 21 consecutive days to complete a 21-day cycle.	Phase 2: Navitoclax 100 mg n=4 participants at risk Navitoclax 100 mg in subjects with CLL who had relapsed following any (but no more than 5) prior myelosuppressive/chemotherapy treatment regimen(s).	Phase 2: Navitoclax 250 mg n=27 participants at risk Navitoclax 250 mg in subjects with CLL who had relapsed following any (but no more than 5) prior myelosuppressive/chemotherapy treatment regimen(s).
Blood and lymphatic system disorders ANAEMIA	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	3.7% 1/27 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Blood and lymphatic system disorders FEBRILE NEUTROPENIA	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	16.7% 1/6 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	3.7% 1/27 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Blood and lymphatic system disorders NEUTROPENIA	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Blood and lymphatic system disorders PANCYTOPENIA	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	3.7% 1/27 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Blood and lymphatic system disorders THROMBOCYTOPENIA	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Cardiac disorders ACUTE MYOCARDIAL INFARCTION	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	3.7% 1/27 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Cardiac disorders ANGINA PECTORIS	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	3.7% 1/27 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Cardiac disorders MYOCARDIAL INFARCTION	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	16.7% 1/6 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Gastrointestinal disorders ABDOMINAL PAIN	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	3.7% 1/27 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Gastrointestinal disorders CONSTIPATION	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Gastrointestinal disorders NAUSEA	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	3.7% 1/27 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Gastrointestinal disorders RECTAL HAEMORRHAGE	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	3.7% 1/27 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Gastrointestinal disorders SMALL INTESTINAL OBSTRUCTION	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	3.7% 1/27 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
General disorders PYREXIA	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	3.7% 1/27 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Hepatobiliary disorders CHOLELITHIASIS	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	3.7% 1/27 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Infections and infestations ABSCESS LIMB	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Infections and infestations AMOEBIASIS	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	3.7% 1/27 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Infections and infestations APPENDICITIS	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Infections and infestations ASPERGILLUS INFECTION	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	3.7% 1/27 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Infections and infestations BACTERAEMIA	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	3.7% 1/27 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Infections and infestations BRONCHOPULMONARY ASPERGILLOSIS	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	3.7% 1/27 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Infections and infestations CELLULITIS	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Infections and infestations ESCHERICHIA BACTERAEMIA	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	3.7% 1/27 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Infections and infestations ESCHERICHIA URINARY TRACT INFECTION	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	7.4% 2/27 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Infections and infestations GASTROENTERITIS SALMONELLA	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Infections and infestations LOWER RESPIRATORY TRACT INFECTION	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Infections and infestations PHARYNGITIS	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Infections and infestations PNEUMONIA	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	16.7% 1/6 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	7.4% 2/27 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Infections and infestations PNEUMONIA KLEBSIELLA	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	3.7% 1/27 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Infections and infestations PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Infections and infestations PSEUDOMONAL SEPSIS	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	16.7% 1/6 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Metabolism and nutrition disorders GOUT	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Metabolism and nutrition disorders HYPERCALCAEMIA	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	50.0% 2/4 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Metabolism and nutrition disorders TUMOUR LYSIS SYNDROME	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	16.7% 1/6 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	3.7% 1/27 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Musculoskeletal and connective tissue disorders LUMBAR SPINAL STENOSIS	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	3.7% 1/27 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BASAL CELL CARCINOMA	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	16.7% 1/6 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) CHRONIC LYMPHOCYTIC LEUKAEMIA	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	3.7% 1/27 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) COLORECTAL CANCER METASTATIC	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MALIGNANT MELANOMA OF EYELID	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	16.7% 1/6 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) RECTAL ADENOCARCINOMA	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SQUAMOUS CELL CARCINOMA	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SQUAMOUS CELL CARCINOMA OF SKIN	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	16.7% 1/6 • Number of events 5 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	3.7% 1/27 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SUPERFICIAL SPREADING MELANOMA STAGE UNSPECIFIED	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Nervous system disorders DIZZINESS	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	3.7% 1/27 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Nervous system disorders NEURALGIA	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Nervous system disorders SCIATICA	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	3.7% 1/27 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Nervous system disorders SYNCOPE	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Renal and urinary disorders ACUTE KIDNEY INJURY	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	3.7% 1/27 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Renal and urinary disorders URINARY RETENTION	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Respiratory, thoracic and mediastinal disorders ACUTE RESPIRATORY FAILURE	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Respiratory, thoracic and mediastinal disorders BRONCHIECTASIS	33.3% 1/3 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Respiratory, thoracic and mediastinal disorders CHRONIC OBSTRUCTIVE PULMONARY DISEASE	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Respiratory, thoracic and mediastinal disorders PLEURAL EFFUSION	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	3.7% 1/27 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Respiratory, thoracic and mediastinal disorders PNEUMONITIS	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Respiratory, thoracic and mediastinal disorders PULMONARY EMBOLISM	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Nervous system disorders TRANSIENT ISCHEMIC ATTACK	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	3.7% 1/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.

Other adverse events

Other adverse events
Measure	Navitoclax 14/21 Day Cycle: 10 mg n=3 participants at risk Navitoclax 10 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21- day cycle.	Navitoclax 14/21 Day Cycle: 110 mg n=6 participants at risk Navitoclax 110 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21- day cycle.	Navitoclax 14/21 Day Cycle: 200 mg n=3 participants at risk Navitoclax 200 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21- day cycle.	Navitoclax 14/21 Day Cycle: 250 mg n=3 participants at risk Navitoclax 250 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21- day cycle.	Navitoclax 21/21 Day Cycle: 125 mg n=3 participants at risk Navitoclax 125 mg administered for 21 consecutive days to complete a 21-day cycle.	Navitoclax 21/21 Day Cycle: 200 mg n=4 participants at risk Navitoclax 200 mg administered for 21 consecutive days to complete a 21-day cycle.	Navitoclax 21/21 Day Cycle: 250 mg n=3 participants at risk Navitoclax 250 mg administered for 21 consecutive days to complete a 21-day cycle.	Navitoclax 21/21 Day Cycle: 300 mg n=4 participants at risk Navitoclax 300 mg administered for 21 consecutive days to complete a 21-day cycle.	Phase 2: Navitoclax 100 mg n=4 participants at risk Navitoclax 100 mg in subjects with CLL who had relapsed following any (but no more than 5) prior myelosuppressive/chemotherapy treatment regimen(s).	Phase 2: Navitoclax 250 mg n=27 participants at risk Navitoclax 250 mg in subjects with CLL who had relapsed following any (but no more than 5) prior myelosuppressive/chemotherapy treatment regimen(s).
Blood and lymphatic system disorders ANAEMIA	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	16.7% 1/6 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	14.8% 4/27 • Number of events 7 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Blood and lymphatic system disorders LYMPHADENOPATHY	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	3.7% 1/27 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Blood and lymphatic system disorders NEUTROPENIA	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	50.0% 2/4 • Number of events 5 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.9% 7/27 • Number of events 20 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Blood and lymphatic system disorders THROMBOCYTOPENIA	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	16.7% 1/6 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	66.7% 2/3 • Number of events 10 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	66.7% 2/3 • Number of events 10 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 5 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	48.1% 13/27 • Number of events 39 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Cardiac disorders ANGINA PECTORIS	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	16.7% 1/6 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Cardiac disorders BRADYCARDIA	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	3.7% 1/27 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Cardiac disorders CARDIAC FAILURE	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Cardiac disorders VENTRICULAR EXTRASYSTOLES	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Congenital, familial and genetic disorders PHIMOSIS	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Ear and labyrinth disorders EAR CONGESTION	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Ear and labyrinth disorders EAR DISCOMFORT	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Ear and labyrinth disorders EAR PAIN	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	66.7% 2/3 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Endocrine disorders AUTOIMMUNE HYPOTHYROIDISM	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Eye disorders CATARACT	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Eye disorders CONJUNCTIVAL HAEMORRHAGE	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	50.0% 2/4 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Eye disorders DACRYOSTENOSIS ACQUIRED	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Eye disorders ECTROPION	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	16.7% 1/6 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Eye disorders EYE HAEMORRHAGE	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Eye disorders RETINAL HAEMORRHAGE	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Eye disorders SWELLING OF EYELID	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Gastrointestinal disorders ABDOMINAL DISCOMFORT	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	50.0% 2/4 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	11.1% 3/27 • Number of events 6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Gastrointestinal disorders ABDOMINAL PAIN	66.7% 2/3 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	16.7% 1/6 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	7.4% 2/27 • Number of events 3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Gastrointestinal disorders ABDOMINAL PAIN UPPER	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	11.1% 3/27 • Number of events 3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Gastrointestinal disorders CONSTIPATION	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	7.4% 2/27 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Gastrointestinal disorders DENTAL CARIES	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Gastrointestinal disorders DIARRHOEA	33.3% 1/3 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	66.7% 4/6 • Number of events 9 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	100.0% 3/3 • Number of events 15 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	100.0% 3/3 • Number of events 4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	66.7% 2/3 • Number of events 8 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	75.0% 3/4 • Number of events 6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	100.0% 3/3 • Number of events 10 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	75.0% 3/4 • Number of events 9 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	100.0% 4/4 • Number of events 5 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	74.1% 20/27 • Number of events 30 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Gastrointestinal disorders DRY MOUTH	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	3.7% 1/27 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Gastrointestinal disorders DYSPEPSIA	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	18.5% 5/27 • Number of events 6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Gastrointestinal disorders DYSPHAGIA	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	3.7% 1/27 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Gastrointestinal disorders FLATULENCE	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	7.4% 2/27 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Gastrointestinal disorders FREQUENT BOWEL MOVEMENTS	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	3.7% 1/27 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Gastrointestinal disorders GASTROOESOPHAGEAL REFLUX DISEASE	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	7.4% 2/27 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Gastrointestinal disorders GINGIVAL BLEEDING	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	3.7% 1/27 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Gastrointestinal disorders MOUTH ULCERATION	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Gastrointestinal disorders NAUSEA	33.3% 1/3 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	50.0% 3/6 • Number of events 4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	66.7% 2/3 • Number of events 8 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	66.7% 2/3 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	100.0% 3/3 • Number of events 6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	50.0% 2/4 • Number of events 6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	66.7% 2/3 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	50.0% 2/4 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	50.0% 2/4 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	48.1% 13/27 • Number of events 17 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Gastrointestinal disorders NONINFECTIVE GINGIVITIS	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Gastrointestinal disorders ORAL PAIN	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	50.0% 2/4 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Gastrointestinal disorders RECTAL FISSURE	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	16.7% 1/6 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Gastrointestinal disorders RECTAL HAEMORRHAGE	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Gastrointestinal disorders RECTAL POLYP	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Gastrointestinal disorders STOMATITIS	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Gastrointestinal disorders TONGUE ULCERATION	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Gastrointestinal disorders TOOTHACHE	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	7.4% 2/27 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Gastrointestinal disorders VOMITING	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	66.7% 2/3 • Number of events 9 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	50.0% 2/4 • Number of events 3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	18.5% 5/27 • Number of events 5 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
General disorders ADVERSE DRUG REACTION	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
General disorders ASTHENIA	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	16.7% 1/6 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
General disorders CHEST DISCOMFORT	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
General disorders CHEST PAIN	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
General disorders FATIGUE	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	50.0% 3/6 • Number of events 7 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	66.7% 2/3 • Number of events 4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	66.7% 2/3 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	50.0% 2/4 • Number of events 3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	66.7% 2/3 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	37.0% 10/27 • Number of events 14 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
General disorders FEELING HOT	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
General disorders GAIT DISTURBANCE	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
General disorders INFLUENZA LIKE ILLNESS	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	16.7% 1/6 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	3.7% 1/27 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
General disorders OEDEMA	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	16.7% 1/6 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
General disorders OEDEMA PERIPHERAL	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	16.7% 1/6 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.9% 7/27 • Number of events 7 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
General disorders PAIN	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	16.7% 1/6 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	3.7% 1/27 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
General disorders PERIPHERAL SWELLING	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	7.4% 2/27 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
General disorders PYREXIA	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	16.7% 1/6 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	50.0% 2/4 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	14.8% 4/27 • Number of events 5 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
General disorders SECRETION DISCHARGE	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
General disorders VESSEL PUNCTURE SITE PAIN	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Hepatobiliary disorders HYPERBILIRUBINAEMIA	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	3.7% 1/27 • Number of events 4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Immune system disorders ALLERGY TO ARTHROPOD BITE	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Immune system disorders SEASONAL ALLERGY	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	3.7% 1/27 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Infections and infestations ACUTE SINUSITIS	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	16.7% 1/6 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Infections and infestations BRONCHITIS	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	11.1% 3/27 • Number of events 5 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Infections and infestations CELLULITIS	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Infections and infestations CONJUNCTIVITIS	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	3.7% 1/27 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Infections and infestations ESCHERICHIA INFECTION	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Infections and infestations ESCHERICHIA URINARY TRACT INFECTION	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Infections and infestations EYE INFECTION	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Infections and infestations GASTROENTERITIS	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Infections and infestations HAEMOPHILUS INFECTION	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	3.7% 1/27 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Infections and infestations HERPES SIMPLEX	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	50.0% 2/4 • Number of events 3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Infections and infestations HERPES ZOSTER	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Infections and infestations INFLUENZA	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	16.7% 1/6 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	3.7% 1/27 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Infections and infestations LICE INFESTATION	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Infections and infestations LOCALISED INFECTION	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Infections and infestations LOWER RESPIRATORY TRACT INFECTION	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	7.4% 2/27 • Number of events 6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Infections and infestations NASOPHARYNGITIS	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	66.7% 2/3 • Number of events 5 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	18.5% 5/27 • Number of events 7 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Infections and infestations ORAL CANDIDIASIS	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Infections and infestations ORAL HERPES	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	3.7% 1/27 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Infections and infestations OTITIS MEDIA	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Infections and infestations PARONYCHIA	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Infections and infestations PNEUMONIA	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	16.7% 1/6 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Infections and infestations PNEUMONIA KLEBSIELLA	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Infections and infestations RESPIRATORY TRACT INFECTION VIRAL	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Infections and infestations RHINITIS	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Infections and infestations RHINOVIRUS INFECTION	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Infections and infestations SINUSITIS	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	16.7% 1/6 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	100.0% 3/3 • Number of events 3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	3.7% 1/27 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Infections and infestations SKIN INFECTION	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	3.7% 1/27 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Infections and infestations STAPHYLOCOCCAL INFECTION	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	3.7% 1/27 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Infections and infestations TOOTH ABSCESS	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	3.7% 1/27 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	16.7% 1/6 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	66.7% 2/3 • Number of events 5 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	50.0% 2/4 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	29.6% 8/27 • Number of events 11 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Renal and urinary disorders RENAL CYST	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Infections and infestations URINARY TRACT INFECTION	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	66.7% 2/3 • Number of events 3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 5 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	18.5% 5/27 • Number of events 10 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Infections and infestations VASCULAR DEVICE INFECTION	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Infections and infestations VIRAL INFECTION	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	66.7% 2/3 • Number of events 3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	3.7% 1/27 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Infections and infestations VULVOVAGINAL CANDIDIASIS	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Injury, poisoning and procedural complications CONTUSION	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 2/6 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	11.1% 3/27 • Number of events 3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Injury, poisoning and procedural complications FALL	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	7.4% 2/27 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Injury, poisoning and procedural complications HUMERUS FRACTURE	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Injury, poisoning and procedural complications LIGAMENT SPRAIN	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Injury, poisoning and procedural complications MENISCUS INJURY	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Injury, poisoning and procedural complications PROCEDURAL PAIN	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	16.7% 1/6 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Injury, poisoning and procedural complications SKIN ABRASION	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Injury, poisoning and procedural complications SKIN LACERATION	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Injury, poisoning and procedural complications SUNBURN	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Injury, poisoning and procedural complications WOUND	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Investigations ALANINE AMINOTRANSFERASE INCREASED	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	66.7% 2/3 • Number of events 9 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	11.1% 3/27 • Number of events 6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Investigations ASPARTATE AMINOTRANSFERASE INCREASED	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	7.4% 2/27 • Number of events 3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Investigations BLOOD CREATININE INCREASED	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	7.4% 2/27 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Investigations BLOOD GLUCOSE INCREASED	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Investigations BLOOD LACTATE DEHYDROGENASE INCREASED	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	7.4% 2/27 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Investigations BLOOD MAGNESIUM DECREASED	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Investigations ELECTROCARDIOGRAM QT PROLONGED	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Investigations GAMMA-GLUTAMYLTRANSFERASE INCREASED	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Investigations HAEMOGLOBIN DECREASED	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	7.4% 2/27 • Number of events 5 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Investigations HEART RATE IRREGULAR	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Investigations LIPASE INCREASED	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Investigations WEIGHT DECREASED	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	11.1% 3/27 • Number of events 3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Investigations WEIGHT INCREASED	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	3.7% 1/27 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Metabolism and nutrition disorders DECREASED APPETITE	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	16.7% 1/6 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	50.0% 2/4 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	29.6% 8/27 • Number of events 10 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Metabolism and nutrition disorders DEHYDRATION	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Metabolism and nutrition disorders HYPERGLYCAEMIA	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	3.7% 1/27 • Number of events 3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Metabolism and nutrition disorders HYPERPHOSPHATAEMIA	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Metabolism and nutrition disorders HYPERURICAEMIA	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	11.1% 3/27 • Number of events 6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Metabolism and nutrition disorders HYPOKALAEMIA	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Metabolism and nutrition disorders HYPOMAGNESAEMIA	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	16.7% 1/6 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Metabolism and nutrition disorders HYPOVOLAEMIA	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	16.7% 1/6 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Metabolism and nutrition disorders TUMOUR LYSIS SYNDROME	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	16.7% 1/6 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	3.7% 1/27 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Musculoskeletal and connective tissue disorders ARTHRALGIA	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	18.5% 5/27 • Number of events 5 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Metabolism and nutrition disorders VITAMIN D DEFICIENCY	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Musculoskeletal and connective tissue disorders BACK PAIN	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	66.7% 2/3 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	11.1% 3/27 • Number of events 4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Musculoskeletal and connective tissue disorders BONE PAIN	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Musculoskeletal and connective tissue disorders DUPUYTREN'S CONTRACTURE	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Musculoskeletal and connective tissue disorders GROIN PAIN	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Musculoskeletal and connective tissue disorders JOINT SWELLING	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	66.7% 2/3 • Number of events 3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Musculoskeletal and connective tissue disorders LIMB DISCOMFORT	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Musculoskeletal and connective tissue disorders MUSCLE SPASMS	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	16.7% 1/6 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	7.4% 2/27 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL DISCOMFORT	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL PAIN	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	3.7% 1/27 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Musculoskeletal and connective tissue disorders MYALGIA	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Musculoskeletal and connective tissue disorders NECK PAIN	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	7.4% 2/27 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Musculoskeletal and connective tissue disorders OSTEITIS	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Musculoskeletal and connective tissue disorders OSTEOPENIA	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Musculoskeletal and connective tissue disorders OSTEOPOROSIS	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	18.5% 5/27 • Number of events 5 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BASAL CELL CARCINOMA	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 5 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	3.7% 1/27 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) COLORECTAL ADENOMA	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	3.7% 1/27 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SKIN PAPILLOMA	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	3.7% 1/27 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SQUAMOUS CELL CARCINOMA OF SKIN	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Nervous system disorders APHASIA	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Nervous system disorders DIZZINESS	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	14.8% 4/27 • Number of events 4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Nervous system disorders DYSGEUSIA	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	16.7% 1/6 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	3.7% 1/27 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Nervous system disorders HEADACHE	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	11.1% 3/27 • Number of events 4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Nervous system disorders LETHARGY	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	3.7% 1/27 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Nervous system disorders NEUROPATHY PERIPHERAL	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	3.7% 1/27 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Nervous system disorders SENSORY DISTURBANCE	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Nervous system disorders TASTE DISORDER	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	11.1% 3/27 • Number of events 3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Psychiatric disorders AGITATION	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	3.7% 1/27 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Psychiatric disorders ANXIETY	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	16.7% 1/6 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	11.1% 3/27 • Number of events 3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Psychiatric disorders INSOMNIA	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 2/6 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	11.1% 3/27 • Number of events 3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Psychiatric disorders MENTAL STATUS CHANGES	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Renal and urinary disorders DYSURIA	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	3.7% 1/27 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Renal and urinary disorders HAEMATURIA	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Renal and urinary disorders NOCTURIA	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Renal and urinary disorders POLLAKIURIA	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	16.7% 1/6 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Renal and urinary disorders RENAL PAIN	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Reproductive system and breast disorders BENIGN PROSTATIC HYPERPLASIA	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Reproductive system and breast disorders ERECTILE DYSFUNCTION	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Reproductive system and breast disorders PENILE CURVATURE	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Reproductive system and breast disorders PROSTATITIS	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	3.7% 1/27 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Respiratory, thoracic and mediastinal disorders ASTHMA	33.3% 1/3 • Number of events 3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Respiratory, thoracic and mediastinal disorders COUGH	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 2/6 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	66.7% 2/3 • Number of events 4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	50.0% 2/4 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	22.2% 6/27 • Number of events 7 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Respiratory, thoracic and mediastinal disorders DYSPNOEA	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	3.7% 1/27 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Respiratory, thoracic and mediastinal disorders EPISTAXIS	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	66.7% 2/3 • Number of events 5 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	66.7% 2/3 • Number of events 7 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	11.1% 3/27 • Number of events 5 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Respiratory, thoracic and mediastinal disorders HAEMOPTYSIS	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Respiratory, thoracic and mediastinal disorders HAEMOTHORAX	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	16.7% 1/6 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Respiratory, thoracic and mediastinal disorders NASAL CONGESTION	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Respiratory, thoracic and mediastinal disorders OROPHARYNGEAL PAIN	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	66.7% 2/3 • Number of events 5 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	50.0% 2/4 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	7.4% 2/27 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Respiratory, thoracic and mediastinal disorders PRODUCTIVE COUGH	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 2/6 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	3.7% 1/27 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Respiratory, thoracic and mediastinal disorders PULMONARY OEDEMA	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	16.7% 1/6 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Respiratory, thoracic and mediastinal disorders RESPIRATORY TRACT CONGESTION	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	16.7% 1/6 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Respiratory, thoracic and mediastinal disorders SINUS CONGESTION	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Respiratory, thoracic and mediastinal disorders SPUTUM DISCOLOURED	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	16.7% 1/6 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Respiratory, thoracic and mediastinal disorders THROAT IRRITATION	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	16.7% 1/6 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Respiratory, thoracic and mediastinal disorders WHEEZING	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Skin and subcutaneous tissue disorders ACTINIC KERATOSIS	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Skin and subcutaneous tissue disorders ALOPECIA	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	50.0% 2/4 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Skin and subcutaneous tissue disorders BLOOD BLISTER	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	16.7% 1/6 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Skin and subcutaneous tissue disorders COLD SWEAT	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Skin and subcutaneous tissue disorders DERMATOSIS	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Skin and subcutaneous tissue disorders DRY SKIN	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Skin and subcutaneous tissue disorders ERYTHEMA	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Skin and subcutaneous tissue disorders NIGHT SWEATS	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	3.7% 1/27 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Skin and subcutaneous tissue disorders RASH	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	16.7% 1/6 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	50.0% 2/4 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	11.1% 3/27 • Number of events 3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Skin and subcutaneous tissue disorders RASH VESICULAR	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Skin and subcutaneous tissue disorders SKIN DISCOLOURATION	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Skin and subcutaneous tissue disorders SKIN LESION	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	25.0% 1/4 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Skin and subcutaneous tissue disorders URTICARIA	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	16.7% 1/6 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Vascular disorders FLUSHING	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Vascular disorders HAEMATOMA	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	16.7% 1/6 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	3.7% 1/27 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Vascular disorders HYPERTENSION	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	3.7% 1/27 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Vascular disorders HYPOTENSION	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/6 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	33.3% 1/3 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	7.4% 2/27 • Number of events 2 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.
Vascular disorders VASCULITIS	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	16.7% 1/6 • Number of events 1 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/3 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/4 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.	0.00% 0/27 • Adverse events: From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. Time frame for All Cause Mortality: From informed consent to the end of study. Median time on study: 135, 89.5, 608, 441, 299, 307, 561, 152.5, 486.5, 803 days for Ph 1 14/21 Day Cycle 10 mg, 110 mg, 200 mg, 250 mg, Ph 1 21/21 Day Cycle 125 mg, 200 mg, 250 mg, 300mg and Ph 2 100 mg , 250 mg arms, respectively.

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