Trial Outcomes & Findings for Everolimus With or Without Bevacizumab in Treating Patients With Advanced Kidney Cancer That Progressed After First-Line Therapy (NCT NCT01198158)

NCT ID: NCT01198158

Last Updated: 2019-03-06

Results Overview

Overall survival time is defined as the time from randomization to death due to any cause. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

77 participants

Primary outcome timeframe

The time from date of randomization to date of death due to any cause, assessed up to 5.5 years

Results posted on

2019-03-06

Participant Flow

Participant milestones

Participant milestones
Measure	Arm I (Everolimus) Patients receive everolimus 10mg daily orally plus intravenous placebo on day 1 and 15 (control arm) in a 28 day cycle.	Arm II (Everolimus With Bevacizumab) Patients receive everolimus 10mg daily orally plus intravenous bevacizumab 10mg/kg intravenously on day 1 and 15 (experimental arm) in a 28 day cycle.
Overall Study STARTED	41	36
Overall Study COMPLETED	41	36
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Everolimus With or Without Bevacizumab in Treating Patients With Advanced Kidney Cancer That Progressed After First-Line Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I (Everolimus) n=41 Participants Patients receive everolimus 10mg daily orally plus intravenous placebo on day 1 and 15 (control arm) in a 28 day cycle.	Arm II (Everolimus With Bevacizumab) n=36 Participants Patients receive everolimus 10mg daily orally plus intravenous bevacizumab 10mg/kg intravenously on day 1 and 15 (experimental arm) in a 28 day cycle.	Total n=77 Participants Total of all reporting groups
Age, Continuous	62.9 years n=5 Participants	62 years n=7 Participants	62.2 years n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	5 Participants n=7 Participants	18 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants	31 Participants n=7 Participants	59 Participants n=5 Participants
Race/Ethnicity, Customized White	35 Participants n=5 Participants	32 Participants n=7 Participants	67 Participants n=5 Participants
Race/Ethnicity, Customized Non-White	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Region of Enrollment United States	41 Participants n=5 Participants	36 Participants n=7 Participants	77 Participants n=5 Participants
Dominant clear cell histology	34 Participants n=5 Participants	30 Participants n=7 Participants	64 Participants n=5 Participants

PRIMARY outcome

Timeframe: The time from date of randomization to date of death due to any cause, assessed up to 5.5 years

Overall survival time is defined as the time from randomization to death due to any cause. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.

Outcome measures

Outcome measures
Measure	Arm I (Everolimus) n=41 Participants Patients receive everolimus 10mg daily orally plus intravenous placebo on day 1 and 15 (control arm) in a 28 day cycle.	Arm II (Everolimus With Bevacizumab) n=36 Participants Patients receive everolimus 10mg daily orally plus intravenous bevacizumab 10mg/kg intravenously on day 1 and 15 (experimental arm) in a 28 day cycle.
Overall Survival (OS)	27.5 months Interval 14.5 to 34.0	21.8 months Interval 14.8 to 27.2

SECONDARY outcome

Timeframe: The time from randomization to disease progression or death from any cause, assessed up to 5.5 years

Progression free survival (PFS) is defined as the time from the date of randomization to the date of disease progression or death resulting from any cause, whichever comes first. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.

Outcome measures

Outcome measures
Measure	Arm I (Everolimus) n=41 Participants Patients receive everolimus 10mg daily orally plus intravenous placebo on day 1 and 15 (control arm) in a 28 day cycle.	Arm II (Everolimus With Bevacizumab) n=36 Participants Patients receive everolimus 10mg daily orally plus intravenous bevacizumab 10mg/kg intravenously on day 1 and 15 (experimental arm) in a 28 day cycle.
Progression-free Survival (PFS)	7.2 months Interval 3.7 to 9.8	6.9 months Interval 4.1 to 11.2

SECONDARY outcome

Timeframe: Up to 5.5 years

The response rate (percentage) is the percent of patients whose best response was Complete Response (CR) or Partial Response (PR) as defined by RECIST 1.1 criteria. Percentage of successes will be estimated by 100 times the number of successes divided by the total number of evaluable patients.

Outcome measures

Outcome measures
Measure	Arm I (Everolimus) n=41 Participants Patients receive everolimus 10mg daily orally plus intravenous placebo on day 1 and 15 (control arm) in a 28 day cycle.	Arm II (Everolimus With Bevacizumab) n=36 Participants Patients receive everolimus 10mg daily orally plus intravenous bevacizumab 10mg/kg intravenously on day 1 and 15 (experimental arm) in a 28 day cycle.
Objective Response Rate (CR + PR)	17.1 percentage of participants Interval 7.2 to 32.1	16.7 percentage of participants Interval 6.4 to 32.8

SECONDARY outcome

Timeframe: Up to 30 days after completion of study treatment

Population: All patients that started protocol treatment and were assessed for adverse events were included in this endpoint.

The number of patients reporting grade 3 or higher adverse events as graded by the NCI's Common Toxicity Criteria (CTCAE) Version 4 are reported here. A complete list of all reported adverse events is reported in the Adverse Events section of this report.

Outcome measures

Outcome measures
Measure	Arm I (Everolimus) n=38 Participants Patients receive everolimus 10mg daily orally plus intravenous placebo on day 1 and 15 (control arm) in a 28 day cycle.	Arm II (Everolimus With Bevacizumab) n=33 Participants Patients receive everolimus 10mg daily orally plus intravenous bevacizumab 10mg/kg intravenously on day 1 and 15 (experimental arm) in a 28 day cycle.
Toxicities, Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 Grade 3 Adverse event	21 Participants	20 Participants
Toxicities, Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 Grade 4 Adverse event	1 Participants	3 Participants

Adverse Events

Arm I (Everolimus)

Serious events: 9 serious events

Other events: 32 other events

Deaths: 33 deaths

Arm II (Everolimus With Bevacizumab)

Serious events: 11 serious events

Other events: 32 other events

Deaths: 28 deaths

Serious adverse events

Other adverse events

Additional Information

George Philips MBBS, MD, MPH, FACP

Georgetown University Hospital

Phone: 202-444-2198

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	Arm I (Everolimus) n=38 participants at risk Patients receive everolimus 10mg daily orally plus intravenous placebo on day 1 and 15 (control arm) in a 28 day cycle.	Arm II (Everolimus With Bevacizumab) n=33 participants at risk Patients receive everolimus 10mg daily orally plus intravenous bevacizumab 10mg/kg intravenously on day 1 and 15 (experimental arm) in a 28 day cycle.
Skin and subcutaneous tissue disorders Erythema multiforme	2.6% 1/38 • Number of events 1 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	6.1% 2/33 • Number of events 2 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Vascular disorders Hypertension	5.3% 2/38 • Number of events 2 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	9.1% 3/33 • Number of events 3 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Vascular disorders Hypotension	2.6% 1/38 • Number of events 1 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	6.1% 2/33 • Number of events 2 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Blood and lymphatic system disorders Anemia	15.8% 6/38 • Number of events 6 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	24.2% 8/33 • Number of events 9 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Cardiac disorders Aortic valve disease	2.6% 1/38 • Number of events 1 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/33 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Cardiac disorders Sinus tachycardia	2.6% 1/38 • Number of events 1 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/33 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Gastrointestinal disorders Abdominal pain	0.00% 0/38 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	3.0% 1/33 • Number of events 1 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Gastrointestinal disorders Diarrhea	2.6% 1/38 • Number of events 1 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	3.0% 1/33 • Number of events 1 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Gastrointestinal disorders Enterocolitis	0.00% 0/38 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	3.0% 1/33 • Number of events 1 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Gastrointestinal disorders Lower gastrointestinal hemorrhage	0.00% 0/38 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	3.0% 1/33 • Number of events 1 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Gastrointestinal disorders Nausea	2.6% 1/38 • Number of events 1 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/33 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Gastrointestinal disorders Toothache	0.00% 0/38 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	3.0% 1/33 • Number of events 1 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Gastrointestinal disorders Vomiting	2.6% 1/38 • Number of events 1 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/33 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
General disorders Fatigue	18.4% 7/38 • Number of events 7 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	15.2% 5/33 • Number of events 7 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Immune system disorders Allergic reaction	2.6% 1/38 • Number of events 1 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	3.0% 1/33 • Number of events 1 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Infections and infestations Lung infection	0.00% 0/38 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	3.0% 1/33 • Number of events 1 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Infections and infestations Soft tissue infection	2.6% 1/38 • Number of events 1 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/33 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Infections and infestations Urinary tract infection	2.6% 1/38 • Number of events 1 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	3.0% 1/33 • Number of events 1 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Investigations Alanine aminotransferase increased	5.3% 2/38 • Number of events 2 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	6.1% 2/33 • Number of events 2 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Investigations Aspartate aminotransferase increased	7.9% 3/38 • Number of events 3 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	9.1% 3/33 • Number of events 3 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Investigations Cholesterol high	0.00% 0/38 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	9.1% 3/33 • Number of events 3 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Investigations Creatinine increased	13.2% 5/38 • Number of events 5 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	18.2% 6/33 • Number of events 9 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Investigations INR increased	0.00% 0/38 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	3.0% 1/33 • Number of events 1 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Investigations Lipase increased	2.6% 1/38 • Number of events 1 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/33 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Investigations Lymphocyte count decreased	0.00% 0/38 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	3.0% 1/33 • Number of events 1 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Investigations Neutrophil count decreased	2.6% 1/38 • Number of events 1 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/33 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Investigations Platelet count decreased	10.5% 4/38 • Number of events 4 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	12.1% 4/33 • Number of events 4 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Investigations Weight loss	2.6% 1/38 • Number of events 1 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/33 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Metabolism and nutrition disorders Anorexia	2.6% 1/38 • Number of events 1 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/33 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Metabolism and nutrition disorders Dehydration	5.3% 2/38 • Number of events 2 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/33 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Metabolism and nutrition disorders Hyperglycemia	13.2% 5/38 • Number of events 6 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	12.1% 4/33 • Number of events 7 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Metabolism and nutrition disorders Hypertriglyceridemia	7.9% 3/38 • Number of events 3 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	12.1% 4/33 • Number of events 7 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Metabolism and nutrition disorders Hypokalemia	0.00% 0/38 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	3.0% 1/33 • Number of events 1 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/38 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	6.1% 2/33 • Number of events 2 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Nervous system disorders Depressed level of consciousness	0.00% 0/38 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	3.0% 1/33 • Number of events 1 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Nervous system disorders Seizure	0.00% 0/38 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	3.0% 1/33 • Number of events 1 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Nervous system disorders Syncope	5.3% 2/38 • Number of events 2 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/33 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Renal and urinary disorders Proteinuria	0.00% 0/38 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	6.1% 2/33 • Number of events 2 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Renal and urinary disorders Renal hemorrhage	0.00% 0/38 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	3.0% 1/33 • Number of events 1 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Renal and urinary disorders Urinary tract obstruction	0.00% 0/38 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	3.0% 1/33 • Number of events 1 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.

Other adverse events
Measure	Arm I (Everolimus) n=38 participants at risk Patients receive everolimus 10mg daily orally plus intravenous placebo on day 1 and 15 (control arm) in a 28 day cycle.	Arm II (Everolimus With Bevacizumab) n=33 participants at risk Patients receive everolimus 10mg daily orally plus intravenous bevacizumab 10mg/kg intravenously on day 1 and 15 (experimental arm) in a 28 day cycle.
Blood and lymphatic system disorders Anemia	57.9% 22/38 • Number of events 163 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	63.6% 21/33 • Number of events 116 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Cardiac disorders Atrial flutter	2.6% 1/38 • Number of events 1 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/33 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Cardiac disorders Sinus bradycardia	0.00% 0/38 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	3.0% 1/33 • Number of events 1 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Gastrointestinal disorders Abdominal pain	0.00% 0/38 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	3.0% 1/33 • Number of events 1 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Gastrointestinal disorders Colitis	0.00% 0/38 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	3.0% 1/33 • Number of events 1 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Gastrointestinal disorders Constipation	2.6% 1/38 • Number of events 1 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	3.0% 1/33 • Number of events 1 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Gastrointestinal disorders Diarrhea	21.1% 8/38 • Number of events 27 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	45.5% 15/33 • Number of events 41 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Gastrointestinal disorders Mucositis oral	28.9% 11/38 • Number of events 16 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	21.2% 7/33 • Number of events 7 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Gastrointestinal disorders Nausea	0.00% 0/38 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	6.1% 2/33 • Number of events 2 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Gastrointestinal disorders Toothache	0.00% 0/38 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	3.0% 1/33 • Number of events 1 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Gastrointestinal disorders Vomiting	7.9% 3/38 • Number of events 3 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	12.1% 4/33 • Number of events 6 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
General disorders Edema limbs	0.00% 0/38 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	6.1% 2/33 • Number of events 2 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
General disorders Fatigue	52.6% 20/38 • Number of events 116 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	69.7% 23/33 • Number of events 92 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
General disorders Pain	0.00% 0/38 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	3.0% 1/33 • Number of events 1 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Immune system disorders Allergic reaction	7.9% 3/38 • Number of events 4 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	15.2% 5/33 • Number of events 7 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Infections and infestations Abdominal infection	0.00% 0/38 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	3.0% 1/33 • Number of events 1 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Infections and infestations Tooth infection	0.00% 0/38 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	3.0% 1/33 • Number of events 1 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Infections and infestations Wound infection	2.6% 1/38 • Number of events 1 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	3.0% 1/33 • Number of events 1 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Injury, poisoning and procedural complications Wound dehiscence	0.00% 0/38 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	3.0% 1/33 • Number of events 1 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Investigations Alanine aminotransferase increased	15.8% 6/38 • Number of events 8 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	12.1% 4/33 • Number of events 7 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Investigations Alkaline phosphatase increased	2.6% 1/38 • Number of events 1 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/33 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Investigations Aspartate aminotransferase increased	26.3% 10/38 • Number of events 12 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	21.2% 7/33 • Number of events 22 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Investigations CD4 lymphocytes decreased	0.00% 0/38 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	3.0% 1/33 • Number of events 1 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Investigations Cholesterol high	44.7% 17/38 • Number of events 92 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	51.5% 17/33 • Number of events 63 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Investigations Creatinine increased	39.5% 15/38 • Number of events 75 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	66.7% 22/33 • Number of events 87 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Investigations Lymphocyte count decreased	0.00% 0/38 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	3.0% 1/33 • Number of events 1 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Investigations Neutrophil count decreased	15.8% 6/38 • Number of events 13 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	6.1% 2/33 • Number of events 2 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Investigations Platelet count decreased	15.8% 6/38 • Number of events 35 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	39.4% 13/33 • Number of events 31 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Investigations Weight loss	0.00% 0/38 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	6.1% 2/33 • Number of events 6 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Metabolism and nutrition disorders Anorexia	5.3% 2/38 • Number of events 4 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/33 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Metabolism and nutrition disorders Hyperglycemia	55.3% 21/38 • Number of events 86 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	63.6% 21/33 • Number of events 90 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Metabolism and nutrition disorders Hypertriglyceridemia	60.5% 23/38 • Number of events 100 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	72.7% 24/33 • Number of events 90 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Metabolism and nutrition disorders Hypoalbuminemia	2.6% 1/38 • Number of events 1 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/33 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Metabolism and nutrition disorders Hypokalemia	0.00% 0/38 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	3.0% 1/33 • Number of events 1 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/38 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	3.0% 1/33 • Number of events 1 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Metabolism and nutrition disorders Hypophosphatemia	2.6% 1/38 • Number of events 1 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/33 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Musculoskeletal and connective tissue disorders Back pain	2.6% 1/38 • Number of events 1 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/33 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	2.6% 1/38 • Number of events 1 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/33 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/38 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	3.0% 1/33 • Number of events 1 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/38 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	3.0% 1/33 • Number of events 1 • Up to 30 days after completion of study treatment Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients with at least 1 cycle of tx and 1 AE form. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.