Trial Outcomes & Findings for TORC1/2 Inhibitor MLN0128 and Bevacizumab in Treating Patients With Recurrent Glioblastoma or Advanced Solid Tumors (NCT NCT02142803)

Last Updated: 2025-11-13

Results Overview

Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (R2PD) of TORC1/2 inhibitor MLN0128, determined according to incidence of dose-limiting toxicity, as graded using the National Cancer Institute (NCI) CTCAE version 4.0

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE1

Target enrollment

50 participants

Primary outcome timeframe

28 days

Results posted on

2025-11-13

Participant Flow

Participant milestones

Participant milestones
Measure	Stage 1 - Dose Level 1 Stage 1 (Dose Finding/Escalation Stage) - Dose Level 1: * 3 mg MLN0128 daily * \+ 10 mg/kg bevacizumab every 2 weeks	Stage 1 - Dose Level 2 Stage 1 (Dose Finding/Escalation Stage) - Dose Level 2: * 4 mg MLN0128 daily * \+ 10 mg/kg bevacizumab every 2 weeks	Stage 1 - Dose Level 3 Stage 1 (Dose Finding/Escalation Stage) - Dose Level 3: * 5 mg MLN0128 daily * \+ 10 mg/kg bevacizumab every 2 weeks	Stage 2 - Maximum Tolerated Dose (MTD) Stage 2 - Expansion Cohort at Dose Level 3 - the Maximum Tolerated Dose (MTD) / Recommended Phase 2 Dose (RP2D): * 5 mg MLN0128 daily * \+ 10 mg/kg bevacizumab every 2 weeks
Registration to Initiation of Therapy STARTED	3	3	6	38
Registration to Initiation of Therapy COMPLETED	3	3	6	37
Registration to Initiation of Therapy NOT COMPLETED	0	0	0	1
Study Therapy STARTED	3	3	6	37
Study Therapy COMPLETED	3	3	6	37
Study Therapy NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Stage 1 - Dose Level 1 Stage 1 (Dose Finding/Escalation Stage) - Dose Level 1: * 3 mg MLN0128 daily * \+ 10 mg/kg bevacizumab every 2 weeks	Stage 1 - Dose Level 2 Stage 1 (Dose Finding/Escalation Stage) - Dose Level 2: * 4 mg MLN0128 daily * \+ 10 mg/kg bevacizumab every 2 weeks	Stage 1 - Dose Level 3 Stage 1 (Dose Finding/Escalation Stage) - Dose Level 3: * 5 mg MLN0128 daily * \+ 10 mg/kg bevacizumab every 2 weeks	Stage 2 - Maximum Tolerated Dose (MTD) Stage 2 - Expansion Cohort at Dose Level 3 - the Maximum Tolerated Dose (MTD) / Recommended Phase 2 Dose (RP2D): * 5 mg MLN0128 daily * \+ 10 mg/kg bevacizumab every 2 weeks
Registration to Initiation of Therapy Withdrawal by Subject	0	0	0	1

Baseline Characteristics

TORC1/2 Inhibitor MLN0128 and Bevacizumab in Treating Patients With Recurrent Glioblastoma or Advanced Solid Tumors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dose Level 1 n=3 Participants 3 mg/day MLN0128	Dose Level 2 n=3 Participants 4 mg/day MLN0128	Dose Level 3 (MTD) n=43 Participants 5 mg/day MLN0128	Total n=49 Participants Total of all reporting groups
Age, Continuous	56 years n=10 Participants	42 years n=10 Participants	59 years n=20 Participants	59 years n=45 Participants
Sex: Female, Male Female	1 Participants n=10 Participants	2 Participants n=10 Participants	35 Participants n=20 Participants	38 Participants n=45 Participants
Sex: Female, Male Male	2 Participants n=10 Participants	1 Participants n=10 Participants	8 Participants n=20 Participants	11 Participants n=45 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=10 Participants	0 Participants n=10 Participants	1 Participants n=20 Participants	1 Participants n=45 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=10 Participants	3 Participants n=10 Participants	41 Participants n=20 Participants	47 Participants n=45 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=10 Participants	0 Participants n=10 Participants	1 Participants n=20 Participants	1 Participants n=45 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants	0 Participants n=45 Participants
Race (NIH/OMB) Asian	0 Participants n=10 Participants	1 Participants n=10 Participants	1 Participants n=20 Participants	2 Participants n=45 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants	0 Participants n=45 Participants
Race (NIH/OMB) Black or African American	0 Participants n=10 Participants	0 Participants n=10 Participants	1 Participants n=20 Participants	1 Participants n=45 Participants
Race (NIH/OMB) White	3 Participants n=10 Participants	2 Participants n=10 Participants	39 Participants n=20 Participants	44 Participants n=45 Participants
Race (NIH/OMB) More than one race	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants	0 Participants n=45 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=10 Participants	0 Participants n=10 Participants	2 Participants n=20 Participants	2 Participants n=45 Participants
Baseline Eastern Cooperative Oncology Group (ECOG) Performance Status	0 units on a scale n=10 Participants	0 units on a scale n=10 Participants	1 units on a scale n=20 Participants	1 units on a scale n=45 Participants

PRIMARY outcome

Timeframe: 28 days

Outcome measures

Outcome measures
Measure	Stage 1: Dose Escalation to Estimate MTD/RP2D n=12 Participants Participants enrolled onto Stage 1 - Dose escalation to estimate MTD/RP2D	Dose Level 2 - 4 mg MLN0128 Daily Stage 1 - Dose Level 2 participants: * 4 mg MLN0128 daily * \+ 10 mg/kg bevacizumab every 2 weeks	Dose Level 3 - 5 mg MLN0128 Daily Inclusive of both Stage 1 - Dose Level 3 participants and Stage 2 participants treated at the MTD: * 5 mg MLN0128 daily * \+ 10 mg/kg bevacizumab every 2 weeks
Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (R2PD) of Daily Oral MLN0128 When Administered With Bevacizumab	5 mg/day	—	—

PRIMARY outcome

Timeframe: Up to 2 years

Population: AEs on the study are reported by dose level.

Most common related toxicities that led to dose hold/reductions (AEs graded according to NCI CTCAE version 4.0). Safety assessed through summaries of adverse events, changes in selected laboratory test results, changes in vital signs, and TORC1/2 inhibitor MLN0128 and bevacizumab exposure.

Outcome measures

Outcome measures
Measure	Stage 1: Dose Escalation to Estimate MTD/RP2D n=3 Participants Participants enrolled onto Stage 1 - Dose escalation to estimate MTD/RP2D	Dose Level 2 - 4 mg MLN0128 Daily n=3 Participants Stage 1 - Dose Level 2 participants: * 4 mg MLN0128 daily * \+ 10 mg/kg bevacizumab every 2 weeks	Dose Level 3 - 5 mg MLN0128 Daily n=43 Participants Inclusive of both Stage 1 - Dose Level 3 participants and Stage 2 participants treated at the MTD: * 5 mg MLN0128 daily * \+ 10 mg/kg bevacizumab every 2 weeks
Most Common Related Toxicities That Led to Dose Hold/Reductions Grade 1/2 Fever	0 participants	0 participants	1 participants
Most Common Related Toxicities That Led to Dose Hold/Reductions Grade 1/2 Hyperglycemia	0 participants	0 participants	1 participants
Most Common Related Toxicities That Led to Dose Hold/Reductions Grade 1/2 Hypertriglyceridemia	0 participants	1 participants	1 participants
Most Common Related Toxicities That Led to Dose Hold/Reductions Grade 1/2 Lymphopenia	0 participants	0 participants	1 participants
Most Common Related Toxicities That Led to Dose Hold/Reductions Grade 1/2 Nausea	0 participants	0 participants	3 participants
Most Common Related Toxicities That Led to Dose Hold/Reductions Grade 1/2 Oral mucositis	0 participants	0 participants	4 participants
Most Common Related Toxicities That Led to Dose Hold/Reductions Grade 1/2 Pruritis	0 participants	0 participants	6 participants
Most Common Related Toxicities That Led to Dose Hold/Reductions Grade 1/2 Pulmonary emboli	0 participants	0 participants	1 participants
Most Common Related Toxicities That Led to Dose Hold/Reductions Grade 1/2 Rash	0 participants	1 participants	11 participants
Most Common Related Toxicities That Led to Dose Hold/Reductions Grade 1/2 Thrombocytopenia	0 participants	0 participants	6 participants
Most Common Related Toxicities That Led to Dose Hold/Reductions Grade 1/2 Vomiting	1 participants	0 participants	0 participants
Most Common Related Toxicities That Led to Dose Hold/Reductions Grade 3 Altered mental status	0 participants	0 participants	2 participants
Most Common Related Toxicities That Led to Dose Hold/Reductions Grade 3 Colon obstruction	0 participants	0 participants	1 participants
Most Common Related Toxicities That Led to Dose Hold/Reductions Grade 3 Diarrhea	0 participants	0 participants	1 participants
Most Common Related Toxicities That Led to Dose Hold/Reductions Grade 3 Fatigue	0 participants	0 participants	3 participants
Most Common Related Toxicities That Led to Dose Hold/Reductions Grade 3 Hypercholesterolemia	0 participants	1 participants	2 participants
Most Common Related Toxicities That Led to Dose Hold/Reductions Grade 3 Hypokalemia	0 participants	0 participants	2 participants
Most Common Related Toxicities That Led to Dose Hold/Reductions Grade 3 Hypophosphatemia	0 participants	0 participants	1 participants
Most Common Related Toxicities That Led to Dose Hold/Reductions Grade 3 Lymphopenia	0 participants	0 participants	1 participants
Most Common Related Toxicities That Led to Dose Hold/Reductions Grade 3 Oral mucositis	0 participants	0 participants	5 participants
Most Common Related Toxicities That Led to Dose Hold/Reductions Grade 3 Pruritus	0 participants	1 participants	3 participants
Most Common Related Toxicities That Led to Dose Hold/Reductions Grade 3 Rash	0 participants	0 participants	10 participants
Most Common Related Toxicities That Led to Dose Hold/Reductions Grade 3 Thrombocytopenia	0 participants	0 participants	1 participants
Most Common Related Toxicities That Led to Dose Hold/Reductions Grade 3 Vomiting	0 participants	0 participants	1 participants
Most Common Related Toxicities That Led to Dose Hold/Reductions Grade 1/2 Abdominal pain	0 participants	0 participants	2 participants
Most Common Related Toxicities That Led to Dose Hold/Reductions Grade 1/2 Acute kidney injury	0 participants	0 participants	2 participants
Most Common Related Toxicities That Led to Dose Hold/Reductions Grade 1/2 Anorexia	0 participants	0 participants	2 participants
Most Common Related Toxicities That Led to Dose Hold/Reductions Grade 1/2 Constipation	0 participants	0 participants	2 participants
Most Common Related Toxicities That Led to Dose Hold/Reductions Grade 1/2 Dehydration	0 participants	0 participants	3 participants
Most Common Related Toxicities That Led to Dose Hold/Reductions Grade 1/2 Diarrhea	0 participants	1 participants	5 participants
Most Common Related Toxicities That Led to Dose Hold/Reductions Grade 1/2 Fatigue	0 participants	0 participants	8 participants

SECONDARY outcome

Timeframe: Up to 2 years

Population: * Given the limited sample sizes for Dose Levels 1 \& 2 (3 patients each), the #s presented here may not be statistically valid. * Censoring \& Final PFS #s: 9 patients treated @ Dose Level 3 were censored from PFS analysis for initiation of new therapy or withdrawal of consent. 2 additional patients treated at Dose Level 3 were censored from PFS analysis because they never had a useable scan on study.

Progression is defined as follows: 1. Non-GBM Solid Tumors (Endometrial \& Ovarian Cancers) - using Response Evaluation Criteria In Solid Tumors Criteria (RECIST) guideline (v.1.1): * Target Lesions: \>/= 20% increase in the sum of the longest diameters of target lesions. The sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. * Non-Target Lesions: The appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. 2. GBM - Using the Response Assessment in Neuro-Oncology (RANO) criteria, any of the criteria below qualify for progression: * \>/= 25% increase in sum of the products of perpendicular diameters of enhancing lesions on stable/increasing dose of corticosteroids * Significant increase in T2/FLAIR non-enhancing lesion on stable/increasing dose of corticosteroids * Any new lesion * Clear clinical deterioration not attributable to other cause

Outcome measures

Outcome measures
Measure	Stage 1: Dose Escalation to Estimate MTD/RP2D n=3 Participants Participants enrolled onto Stage 1 - Dose escalation to estimate MTD/RP2D	Dose Level 2 - 4 mg MLN0128 Daily n=3 Participants Stage 1 - Dose Level 2 participants: * 4 mg MLN0128 daily * \+ 10 mg/kg bevacizumab every 2 weeks	Dose Level 3 - 5 mg MLN0128 Daily n=33 Participants Inclusive of both Stage 1 - Dose Level 3 participants and Stage 2 participants treated at the MTD: * 5 mg MLN0128 daily * \+ 10 mg/kg bevacizumab every 2 weeks
Progression-free Survival (PFS)	1.6 months Interval 1.0 to Sample size of 3 patients is too low.	7.3 months Interval 2.1 to Sample size of 3 patients is too low.	5.4 months Interval 2.8 to 7.4

SECONDARY outcome

Timeframe: Up to 2 years

Objective Response Rate (ORR), defined as a Complete Response (CR) or Partial Response (PR) utilizing: 1. RECIST criteria v.1.1 (Endometrial \& Ovarian Cancers): * CR: Disappearance of all target \& non-target lesions (+ normalization of tumor marker level) * PR: \>/= 30% decrease in sum of the longest diameters of target lesions (from baseline) \& no new lesions 2. RANO criteria (GBM patients): * CR: * Disappearance of all enhancing measurable \& non-measurable disease (sustained \>/= 4 wks) * No new lesions * No steroids (physiologic replacement doses only) * Stable or improved non-enhancing lesions * Clinically stable or improved * PR: * \>/= 50% decrease compared to baseline in the sum of products of perpendicular diameters of all measurable enhancing lesions (sustained \>/= 4 wks) * No progression of non-measurable disease * No new lesions * Steroid \</= dose at time of baseline scan * Stable or improved non-enhancing lesions * Clinically stable or improved

Outcome measures

Outcome measures
Measure	Stage 1: Dose Escalation to Estimate MTD/RP2D n=3 Participants Participants enrolled onto Stage 1 - Dose escalation to estimate MTD/RP2D	Dose Level 2 - 4 mg MLN0128 Daily n=3 Participants Stage 1 - Dose Level 2 participants: * 4 mg MLN0128 daily * \+ 10 mg/kg bevacizumab every 2 weeks	Dose Level 3 - 5 mg MLN0128 Daily n=43 Participants Inclusive of both Stage 1 - Dose Level 3 participants and Stage 2 participants treated at the MTD: * 5 mg MLN0128 daily * \+ 10 mg/kg bevacizumab every 2 weeks
Objective Response Rate (ORR) Complete Response	1 Participants	0 Participants	0 Participants
Objective Response Rate (ORR) Partial Response	0 Participants	0 Participants	8 Participants
Objective Response Rate (ORR) Stable Disease	0 Participants	2 Participants	20 Participants
Objective Response Rate (ORR) Progressive Disease	2 Participants	1 Participants	7 Participants
Objective Response Rate (ORR) Unevaluable	0 Participants	0 Participants	8 Participants

SECONDARY outcome

Timeframe: Up to 4 years

Population: * Given the limited sample sizes for Dose Levels 1 \& 2 (3 \& 2 patients respectively), the #s presented here may not be statistically valid. * Censoring \& Final OS #s: 1 patient treated at Dose Level 2 and 6 patients treated at Dose Level 3 were censored from OS analysis for withdrawal of consent or lost to follow-up, and were not followed for survival to their death.

Overall Survival (OS) listed for all patients by dose level.

Outcome measures

Outcome measures
Measure	Stage 1: Dose Escalation to Estimate MTD/RP2D n=3 Participants Participants enrolled onto Stage 1 - Dose escalation to estimate MTD/RP2D	Dose Level 2 - 4 mg MLN0128 Daily n=2 Participants Stage 1 - Dose Level 2 participants: * 4 mg MLN0128 daily * \+ 10 mg/kg bevacizumab every 2 weeks	Dose Level 3 - 5 mg MLN0128 Daily n=36 Participants Inclusive of both Stage 1 - Dose Level 3 participants and Stage 2 participants treated at the MTD: * 5 mg MLN0128 daily * \+ 10 mg/kg bevacizumab every 2 weeks
Overall Survival (OS)	7.9 months Interval 2.0 to Sample size of 3 patients is too small.	11.6 months Interval 3.7 to Sample size of 2 patients is too small.	9.3 months Interval 6.0 to 13.5

SECONDARY outcome

Timeframe: Up to 2 years

Number of Participants with Toxicities Leading to Missed Doses or Delays

Outcome measures

Outcome measures
Measure	Stage 1: Dose Escalation to Estimate MTD/RP2D n=3 Participants Participants enrolled onto Stage 1 - Dose escalation to estimate MTD/RP2D	Dose Level 2 - 4 mg MLN0128 Daily n=3 Participants Stage 1 - Dose Level 2 participants: * 4 mg MLN0128 daily * \+ 10 mg/kg bevacizumab every 2 weeks	Dose Level 3 - 5 mg MLN0128 Daily n=43 Participants Inclusive of both Stage 1 - Dose Level 3 participants and Stage 2 participants treated at the MTD: * 5 mg MLN0128 daily * \+ 10 mg/kg bevacizumab every 2 weeks
Number of Participants With Toxicities Leading to Missed Doses or Delays	1 participants	1 participants	33 participants

SECONDARY outcome

Timeframe: Up to 2 years

Number of patients who had to have their MLN0128 dose reduced while on study.

Outcome measures

Outcome measures
Measure	Stage 1: Dose Escalation to Estimate MTD/RP2D n=3 Participants Participants enrolled onto Stage 1 - Dose escalation to estimate MTD/RP2D	Dose Level 2 - 4 mg MLN0128 Daily n=3 Participants Stage 1 - Dose Level 2 participants: * 4 mg MLN0128 daily * \+ 10 mg/kg bevacizumab every 2 weeks	Dose Level 3 - 5 mg MLN0128 Daily n=43 Participants Inclusive of both Stage 1 - Dose Level 3 participants and Stage 2 participants treated at the MTD: * 5 mg MLN0128 daily * \+ 10 mg/kg bevacizumab every 2 weeks
Number of Participants Who Had an MLN0128 Dose-Reduction On Study	0 Participants	2 Participants	24 Participants

SECONDARY outcome

Timeframe: Up to 2 years

Number of patients that discontinue study drugs due to treatment related toxicity; percentage will be summarized.

Outcome measures

Outcome measures
Measure	Stage 1: Dose Escalation to Estimate MTD/RP2D n=3 Participants Participants enrolled onto Stage 1 - Dose escalation to estimate MTD/RP2D	Dose Level 2 - 4 mg MLN0128 Daily n=3 Participants Stage 1 - Dose Level 2 participants: * 4 mg MLN0128 daily * \+ 10 mg/kg bevacizumab every 2 weeks	Dose Level 3 - 5 mg MLN0128 Daily n=43 Participants Inclusive of both Stage 1 - Dose Level 3 participants and Stage 2 participants treated at the MTD: * 5 mg MLN0128 daily * \+ 10 mg/kg bevacizumab every 2 weeks
Number of Patients That Discontinue Study Drugs Due to Treatment Related Toxicity	0 Participants	0 Participants	10 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 2-3 hours post-dose day 15 of course 1 and day 1 of course 2

Plasma and CSF PK levels of TORC1/2 inhibitor MLN0128 obtained before and after bevacizumab administration will be evaluated and summarized. The ration of plasma to CSF PK levels will also be summarized.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

The biomarkers predicting response to mechanistic target of rapamycin (mTOR) inhibitor activity will be resulted by dose level and response status.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to within 7 days after last study drug or within 7 days after decision to end treatment

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to day 1 of last course of treatment

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Outcome measures

Outcome data not reported

Adverse Events

Dose Level 1 - 3 mg MLN0128 Daily

Serious events: 0 serious events

Other events: 3 other events

Deaths: 3 deaths

Dose Level 2 - 4 mg MLN0128 Daily

Serious events: 0 serious events

Other events: 3 other events

Deaths: 2 deaths

Dose Level 3 - 5 mg MLN0128 Daily

Serious events: 19 serious events

Other events: 43 other events

Deaths: 36 deaths

Serious adverse events

Other adverse events

Additional Information

Christine Sceppa McCluskey

Dana Farber Cancer Institute

Phone: 617-632-5394

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Serious adverse events
Measure	Dose Level 1 - 3 mg MLN0128 Daily n=3 participants at risk Stage 1 - Dose Level 1 participants: * 3 mg MLN0128 daily * \+ 10 mg/kg bevacizumab every 2 weeks	Dose Level 2 - 4 mg MLN0128 Daily n=3 participants at risk Stage 1 - Dose Level 2 participants: * 4 mg MLN0128 daily * \+ 10 mg/kg bevacizumab every 2 weeks	Dose Level 3 - 5 mg MLN0128 Daily n=43 participants at risk Inclusive of both Stage 1 - Dose Level 3 participants and Stage 2 participants treated at the MTD: * 5 mg MLN0128 daily * \+ 10 mg/kg bevacizumab every 2 weeks
Musculoskeletal and connective tissue disorders Neck Pain	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	2.3% 1/43 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).
Infections and infestations Urinary Tract Infection	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	2.3% 1/43 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).
General disorders Fatigue	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	9.3% 4/43 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).
General disorders Fever	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	2.3% 1/43 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).
Psychiatric disorders Confusion	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	7.0% 3/43 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).
General disorders Death NOS	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	4.7% 2/43 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).
Nervous system disorders Dysphasia	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	2.3% 1/43 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	9.3% 4/43 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).
Gastrointestinal disorders Colonic obstruction	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	4.7% 2/43 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).
Gastrointestinal disorders Constipation	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	2.3% 1/43 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).
Gastrointestinal disorders Diarrhea	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	4.7% 2/43 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).
Gastrointestinal disorders Mucositis oral	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	4.7% 2/43 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).
Gastrointestinal disorders Nausea	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	2.3% 1/43 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).
Gastrointestinal disorders Rectal hemorrhage	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	2.3% 1/43 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).
Gastrointestinal disorders Vomiting	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	2.3% 1/43 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).
General disorders Non-cardiac chest pain	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	2.3% 1/43 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).
General disorders Pain	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	2.3% 1/43 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).
Infections and infestations Lung infection	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	2.3% 1/43 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).
Infections and infestations Sepsis	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	2.3% 1/43 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).
Infections and infestations Skin infection	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	2.3% 1/43 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).
Injury, poisoning and procedural complications Fall	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	2.3% 1/43 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).
Metabolism and nutrition disorders Anorexia	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	2.3% 1/43 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).
Metabolism and nutrition disorders Dehydration	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	9.3% 4/43 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).
Metabolism and nutrition disorders Hypokalemia	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	2.3% 1/43 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	2.3% 1/43 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).
Musculoskeletal and connective tissue disorders Generalized muscle weakness	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	2.3% 1/43 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Other, specify: Death due to progression of endometrial cancer	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	4.7% 2/43 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).
Nervous system disorders Intracranial hemorrhage	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	2.3% 1/43 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).
Nervous system disorders Seizure	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	2.3% 1/43 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).
Psychiatric disorders Other, specify - mood alteration	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	2.3% 1/43 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).
Renal and urinary disorders Acute kidney injury	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	2.3% 1/43 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	2.3% 1/43 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).
Skin and subcutaneous tissue disorders Pruritis	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	2.3% 1/43 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	7.0% 3/43 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).
Vascular disorders Hypotension	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	2.3% 1/43 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).
Vascular disorders Thromboembolic event	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	2.3% 1/43 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).
Metabolism and nutrition disorders Hyponatremia	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	2.3% 1/43 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).

Other adverse events
Measure	Dose Level 1 - 3 mg MLN0128 Daily n=3 participants at risk Stage 1 - Dose Level 1 participants: * 3 mg MLN0128 daily * \+ 10 mg/kg bevacizumab every 2 weeks	Dose Level 2 - 4 mg MLN0128 Daily n=3 participants at risk Stage 1 - Dose Level 2 participants: * 4 mg MLN0128 daily * \+ 10 mg/kg bevacizumab every 2 weeks	Dose Level 3 - 5 mg MLN0128 Daily n=43 participants at risk Inclusive of both Stage 1 - Dose Level 3 participants and Stage 2 participants treated at the MTD: * 5 mg MLN0128 daily * \+ 10 mg/kg bevacizumab every 2 weeks
Blood and lymphatic system disorders Anemia	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	20.9% 9/43 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).
Cardiac disorders Sinus tachycardia	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	33.3% 1/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	0.00% 0/43 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).
Gastrointestinal disorders Abdominal pain	33.3% 1/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	16.3% 7/43 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).
Gastrointestinal disorders Constipation	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	33.3% 1/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	30.2% 13/43 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).
Gastrointestinal disorders Diarrhea	33.3% 1/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	66.7% 2/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	48.8% 21/43 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).
Gastrointestinal disorders Dry mouth	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	7.0% 3/43 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).
Gastrointestinal disorders Dyspepsia	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	33.3% 1/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	9.3% 4/43 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).
Gastrointestinal disorders Dysphagia	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	7.0% 3/43 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).
Gastrointestinal disorders Gastroesophageal reflux disease	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	9.3% 4/43 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).
Gastrointestinal disorders Hemorrhoids	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	7.0% 3/43 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).
Gastrointestinal disorders Mucositis oral	33.3% 1/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	33.3% 1/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	51.2% 22/43 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).
Gastrointestinal disorders Nausea	100.0% 3/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	33.3% 1/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	51.2% 22/43 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).
Gastrointestinal disorders Oral dysesthesia	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	7.0% 3/43 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).
Gastrointestinal disorders Oral pain	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	33.3% 1/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	0.00% 0/43 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).
Gastrointestinal disorders Stomach pain	33.3% 1/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	0.00% 0/43 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).
Gastrointestinal disorders Vomiting	33.3% 1/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	66.7% 2/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	27.9% 12/43 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).
General disorders Chills	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	11.6% 5/43 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).
General disorders Edema face	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	33.3% 1/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	0.00% 0/43 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).
General disorders Edema limbs	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	20.9% 9/43 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).
General disorders Fatigue	66.7% 2/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	66.7% 2/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	62.8% 27/43 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).
General disorders Fever	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	7.0% 3/43 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).
General disorders Pain	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	7.0% 3/43 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).
Infections and infestations Skin infection	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	7.0% 3/43 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).
Infections and infestations Tooth infection	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	33.3% 1/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	0.00% 0/43 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).
Infections and infestations Urinary tract infection	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	23.3% 10/43 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).
Injury, poisoning and procedural complications Fall	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	33.3% 1/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	16.3% 7/43 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).
Investigations Alanine aminotransferase increased	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	20.9% 9/43 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).
Investigations Alkaline phosphatase increased	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	25.6% 11/43 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).
Investigations Aspartate aminotransferase increased	33.3% 1/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	25.6% 11/43 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).
Investigations Blood bilirubin increased	33.3% 1/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	0.00% 0/43 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).
Investigations Cholesterol high	33.3% 1/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	33.3% 1/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	37.2% 16/43 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).
Investigations Creatinine increased	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	33.3% 1/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	30.2% 13/43 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).
Investigations Other, specify: LDH Increased	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	18.6% 8/43 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).
Investigations Lymphocyte count decreased	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	33.3% 1/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	37.2% 16/43 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).
Investigations Neutrophil count decreased	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	9.3% 4/43 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).
Investigations Platelet count decreased	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	33.3% 1/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	48.8% 21/43 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).
Investigations Weight loss	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	30.2% 13/43 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).
Investigations White blood cell decreased	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	25.6% 11/43 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).
Metabolism and nutrition disorders Anorexia	33.3% 1/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	66.7% 2/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	48.8% 21/43 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).
Metabolism and nutrition disorders Dehydration	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	0.00% 0/3 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).	9.3% 4/43 • Up to 2 years Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).