Trial Outcomes & Findings for VTX-2337 and Pegylated Liposomal Doxorubicin (PLD) in Patients With Recurrent or Persistent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer (NCT NCT01666444)

NCT ID: NCT01666444

Last Updated: 2019-09-26

Results Overview

Comparison of duration of survival between the 2 treatment groups

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 297 participants
• Primary outcome timeframe: Survival is measured from date of enrollment and randomization on the study until death from any cause, or if alive at last contact, date of last contact.
• Results posted on: 2019-09-26

Participant Flow

Enrollment was initiated on 2012-Aug-13 and terminated on 2014-Apr-11. During this time, 297 patients were enrolled.

Prior to enrollment and treatment assignment, a completed eligibility checklist was electronically checked for completeness and compliance with eligibility criteria. Prior to treatment assignment, patients were stratified by prior platinum free interval (<6 months or >6-12 months) and performance status (0 or 1). Treatments were double-blinded.

Participant milestones

Measure	Pegylated Liposomal Doxorubicin (PLD) + Placebo Pegylated Liposomal Doxorubicin (PLD) 40 mg/m2 plus placebo	Pegylated Liposomal Doxorubicin (PLD)+VTX-2337 (VTX) Pegylated Liposomal Doxorubicin (PLD) 40 mg/m2 plus VTX-2337 3.0 mg/m2
Overall Study STARTED	149	148
Overall Study COMPLETED	147	147
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Measure	Pegylated Liposomal Doxorubicin (PLD) + Placebo Pegylated Liposomal Doxorubicin (PLD) 40 mg/m2 plus placebo	Pegylated Liposomal Doxorubicin (PLD)+VTX-2337 (VTX) Pegylated Liposomal Doxorubicin (PLD) 40 mg/m2 plus VTX-2337 3.0 mg/m2
Overall Study Did not initiate treatment	2	1

Baseline Characteristics

VTX-2337 and Pegylated Liposomal Doxorubicin (PLD) in Patients With Recurrent or Persistent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer

Baseline characteristics by cohort

Measure	Pegylated Liposomal Doxorubicin (PLD) + Placebo n=149 Participants Pegylated Liposomal Doxorubicin (PLD) 40 mg/m2 plus placebo	Pegylated Liposomal Doxorubicin (PLD)+VTX-2337 (VTX) n=148 Participants Pegylated Liposomal Doxorubicin (PLD) 40 mg/m2 plus VTX-2337 3.0 mg/m2	Total n=297 Participants Total of all reporting groups
Age, Continuous	61.6 years n=93 Participants	63.5 years n=4 Participants	62.7 years n=27 Participants
Age, Customized <40 years	4 Participants n=93 Participants	1 Participants n=4 Participants	5 Participants n=27 Participants
Age, Customized 40-49 years	22 Participants n=93 Participants	11 Participants n=4 Participants	33 Participants n=27 Participants
Age, Customized 50-59 years	39 Participants n=93 Participants	42 Participants n=4 Participants	81 Participants n=27 Participants
Age, Customized 60-69 years	50 Participants n=93 Participants	51 Participants n=4 Participants	101 Participants n=27 Participants
Age, Customized 70-79 years	31 Participants n=93 Participants	38 Participants n=4 Participants	69 Participants n=27 Participants
Age, Customized > 79 years	3 Participants n=93 Participants	5 Participants n=4 Participants	8 Participants n=27 Participants
Sex: Female, Male Female	149 Participants n=93 Participants	148 Participants n=4 Participants	297 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=93 Participants	3 Participants n=4 Participants	7 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	143 Participants n=93 Participants	145 Participants n=4 Participants	288 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=93 Participants	0 Participants n=4 Participants	2 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Race (NIH/OMB) Asian	3 Participants n=93 Participants	3 Participants n=4 Participants	6 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	4 Participants n=93 Participants	6 Participants n=4 Participants	10 Participants n=27 Participants
Race (NIH/OMB) White	141 Participants n=93 Participants	137 Participants n=4 Participants	278 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status 0 = Fully active, no restrictions	104 Participants n=93 Participants	105 Participants n=4 Participants	209 Participants n=27 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status 1=Restricted activity;ambulatory;can do light work	45 Participants n=93 Participants	43 Participants n=4 Participants	88 Participants n=27 Participants
Prior Platinum-Free Interval as per Case Report Forms <= 6 months	79 Participants n=93 Participants	72 Participants n=4 Participants	151 Participants n=27 Participants
Prior Platinum-Free Interval as per Case Report Forms > 6 months	70 Participants n=93 Participants	76 Participants n=4 Participants	146 Participants n=27 Participants
Prior Chemotherapy Regimens 1	81 Participants n=93 Participants	69 Participants n=4 Participants	150 Participants n=27 Participants
Prior Chemotherapy Regimens 2	64 Participants n=93 Participants	74 Participants n=4 Participants	138 Participants n=27 Participants
Prior Chemotherapy Regimens 3	4 Participants n=93 Participants	5 Participants n=4 Participants	9 Participants n=27 Participants

PRIMARY outcome

Timeframe: Survival is measured from date of enrollment and randomization on the study until death from any cause, or if alive at last contact, date of last contact.

Population: All enrolled patients

Comparison of duration of survival between the 2 treatment groups

Outcome measures

Measure	Pegylated Liposomal Doxorubicin (PLD) + Placebo n=149 Participants Pegylated Liposomal Doxorubicin (PLD) 40 mg/m2 plus placebo	Pegylated Liposomal Doxorubicin (PLD)+VTX-2337 (VTX) n=148 Participants Pegylated Liposomal Doxorubicin (PLD) 40 mg/m2 plus VTX-2337 3.0 mg/m2
Overall Survival	574 days Interval 242.0 to 1141.0	552 days Interval 240.0 to 869.0

SECONDARY outcome

Timeframe: Progression-free survival is measured from enrollment and randomization on the study until first indication of progression based on irRECIST criteria or death from any cause, or if progression-free at last contact, the date of last disease assessment.

Population: All enrolled patients.

Comparison of PFS between the 2 treatment groups

Outcome measures

Measure	Pegylated Liposomal Doxorubicin (PLD) + Placebo n=149 Participants Pegylated Liposomal Doxorubicin (PLD) 40 mg/m2 plus placebo	Pegylated Liposomal Doxorubicin (PLD)+VTX-2337 (VTX) n=148 Participants Pegylated Liposomal Doxorubicin (PLD) 40 mg/m2 plus VTX-2337 3.0 mg/m2
Progression-free Survival (PFS)	159 days Interval 87.0 to 351.0	147 days Interval 85.0 to 267.0

SECONDARY outcome

Timeframe: Assessed during each cycle of therapy and within 30 days after the last cycle of therapy

Population: All patients who initiated study treatment. There were 147 patients who initiated treatment on each arm.

An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE can be unfavorable and unintended sign, symptom, or disease which is temporally associated with the use of investigational product (IP), whether or not considered related to the IP. A serious AE = an AE occurring at any dose that: • Results in death • Is life- threatening • Requires or prolongs existing inpatient hospitalization • Results in persistent or significant disability/incapacity • Is a congenital anomaly/birth defect; • Constitutes an important medical event. The Investigator assessed the relationship of each AE to IP and graded the severity according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0: Grade (GR) 1 = Mild; asymptomatic or mild symptoms; GR 2 = Moderate (minimal, local or noninvasive intervention indicated); GR 3 = Severe or medically significant; GR 4 = Life-threatening; GR 5 = Death

Outcome measures

Measure	Pegylated Liposomal Doxorubicin (PLD) + Placebo n=147 Participants Pegylated Liposomal Doxorubicin (PLD) 40 mg/m2 plus placebo	Pegylated Liposomal Doxorubicin (PLD)+VTX-2337 (VTX) n=147 Participants Pegylated Liposomal Doxorubicin (PLD) 40 mg/m2 plus VTX-2337 3.0 mg/m2
Frequency and Severity of Adverse Events (AEs) Grade 1	8 participants	3 participants
Frequency and Severity of Adverse Events (AEs) Grade 2	40 participants	44 participants
Frequency and Severity of Adverse Events (AEs) Grade 3	83 participants	90 participants
Frequency and Severity of Adverse Events (AEs) Grade 4	10 participants	3 participants
Frequency and Severity of Adverse Events (AEs) Grade 5	6 participants	7 participants

Adverse Events

Pegylated Liposomal Doxorubicin (PLD) + Placebo

Serious events: 30 serious events

Other events: 147 other events

Deaths: 0 deaths

Pegylated Liposomal Doxorubicin (PLD)+VTX-2337 (VTX)

Serious events: 36 serious events

Other events: 147 other events

Deaths: 0 deaths

Serious adverse events

Measure	Pegylated Liposomal Doxorubicin (PLD) + Placebo n=147 participants at risk Pegylated Liposomal Doxorubicin (PLD) 40 mg/m2 plus placebo	Pegylated Liposomal Doxorubicin (PLD)+VTX-2337 (VTX) n=147 participants at risk Pegylated Liposomal Doxorubicin (PLD) 40 mg/m2 plus VTX-2337 3.0 mg/m2
Blood and lymphatic system disorders Anemia	2.0% 3/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	1.4% 2/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Cardiac disorders Atrial Fibrillation	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Gastrointestinal disorders Constipation	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	1.4% 2/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Gastrointestinal disorders Diarrhea	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	2.7% 4/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Gastrointestinal disorders Vomiting	3.4% 5/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	4.8% 7/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Gastrointestinal disorders Upper Gastrointestinal Hemorrhage	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Gastrointestinal disorders Bloating	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Gastrointestinal disorders Small Intestinal Obstruction	2.0% 3/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Gastrointestinal disorders Abdominal Pain	2.0% 3/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	4.1% 6/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Gastrointestinal disorders Mucositis Oral	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Gastrointestinal disorders Gastrointestinal Disorders - Other	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Gastrointestinal disorders Ileus	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Gastrointestinal disorders Abdominal Distension	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	1.4% 2/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Gastrointestinal disorders Nausea	5.4% 8/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	6.1% 9/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Gastrointestinal disorders Esophageal Ulcer	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Gastrointestinal disorders Esophagitis	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Gastrointestinal disorders Ascites	1.4% 2/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
General disorders Pain	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	1.4% 2/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
General disorders Malaise	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
General disorders Injection Site Reaction	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
General disorders Non-Cardiac Chest Pain	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
General disorders Edema Limbs	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
General disorders Fatigue	1.4% 2/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	2.7% 4/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
General disorders Death Nos	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
General disorders Fever	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	2.0% 3/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
General disorders Chills	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Infections and infestations Sinusitis	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Infections and infestations Sepsis	3.4% 5/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Infections and infestations Lung Infection	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Infections and infestations Cecal Infection	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Infections and infestations Urinary Tract Infection	1.4% 2/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	1.4% 2/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Infections and infestations Enterocolitis Infectious	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Infections and infestations Biliary Tract Infection	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Injury, poisoning and procedural complications Spinal Fracture	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Investigations Lymphocyte Count Decreased	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Investigations Inr Increased	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Investigations Creatinine Increased	2.7% 4/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Investigations Neutrophil Count Decreased	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	1.4% 2/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Investigations Blood Bilirubin Increased	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Investigations White Blood Cell Decreased	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Investigations Aspartate Aminotransferase Increased	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Investigations Alkaline Phosphatase Increased	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Investigations Alanine Aminotransferase Increased	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Metabolism and nutrition disorders Hyponatremia	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Metabolism and nutrition disorders Hypomagnesemia	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Metabolism and nutrition disorders Hypokalemia	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Metabolism and nutrition disorders Hypocalcemia	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Metabolism and nutrition disorders Hypoalbuminemia	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Metabolism and nutrition disorders Hyperglycemia	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Metabolism and nutrition disorders Dehydration	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	1.4% 2/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Metabolism and nutrition disorders Anorexia	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	2.0% 3/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Musculoskeletal and connective tissue disorders Pain In Extremity	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Musculoskeletal and connective tissue disorders Generalized Muscle Weakness	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	1.4% 2/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms Benign, Malignant And Unspecified (Incl	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Nervous system disorders Stroke	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Nervous system disorders Dysarthria	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Nervous system disorders Cognitive Disturbance	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Psychiatric disorders Confusion	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Renal and urinary disorders Urinary Tract Obstruction	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Renal and urinary disorders Acute Kidney Injury	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	1.4% 2/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Respiratory, thoracic and mediastinal disorders Respiratory, Thoracic And Mediastinal Disorders -	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	2.0% 3/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	2.0% 3/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	2.0% 3/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Vascular disorders Thromboembolic Event	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Vascular disorders Hypotension	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Vascular disorders Hypertension	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.

Other adverse events

Measure	Pegylated Liposomal Doxorubicin (PLD) + Placebo n=147 participants at risk Pegylated Liposomal Doxorubicin (PLD) 40 mg/m2 plus placebo	Pegylated Liposomal Doxorubicin (PLD)+VTX-2337 (VTX) n=147 participants at risk Pegylated Liposomal Doxorubicin (PLD) 40 mg/m2 plus VTX-2337 3.0 mg/m2
Injury, poisoning and procedural complications Burn	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Injury, poisoning and procedural complications Bruising	4.1% 6/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	5.4% 8/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Injury, poisoning and procedural complications Ankle Fracture	1.4% 2/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Investigations Investigations - Other	1.4% 2/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	2.7% 4/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Investigations Weight Loss	12.9% 19/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	17.0% 25/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Investigations Weight Gain	3.4% 5/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	2.7% 4/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Investigations Platelet Count Decreased	20.4% 30/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	12.2% 18/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Investigations Lymphocyte Count Decreased	6.8% 10/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	10.2% 15/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Investigations Inr Increased	3.4% 5/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	2.0% 3/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Investigations Hemoglobin Increased	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Investigations Ggt Increased	1.4% 2/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	1.4% 2/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Investigations Electrocardiogram Qt Corrected Interval Prolonged	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Investigations Ejection Fraction Decreased	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	2.0% 3/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Investigations Creatinine Increased	6.1% 9/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	7.5% 11/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Investigations Cholesterol High	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Investigations Neutrophil Count Decreased	40.8% 60/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	36.7% 54/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Investigations Urine Output Decreased	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
General disorders Edema Limbs	12.9% 19/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	25.2% 37/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
General disorders Facial Pain	1.4% 2/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
General disorders Edema Face	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
General disorders Fatigue	74.1% 109/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	86.4% 127/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
General disorders Fever	12.9% 19/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	47.6% 70/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
General disorders Gait Disturbance	1.4% 2/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	1.4% 2/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
General disorders Chills	17.0% 25/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	62.6% 92/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
General disorders Infusion Related Reaction	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	3.4% 5/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Hepatobiliary disorders Hepatobiliary Disorders - Other	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Hepatobiliary disorders Cholecystitis	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Immune system disorders Anaphylaxis	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Immune system disorders Allergic Reaction	2.7% 4/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	2.7% 4/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Immune system disorders Cytokine Release Syndrome	1.4% 2/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	16.3% 24/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Immune system disorders Immune System Disorders - Other	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Infections and infestations Infections And Infestations - Other	2.7% 4/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	1.4% 2/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Infections and infestations Wound Infection	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Infections and infestations Upper Respiratory Infection	2.0% 3/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	2.7% 4/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Infections and infestations Tooth Infection	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Infections and infestations Stoma Site Infection	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Infections and infestations Vulval Infection	1.4% 2/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Infections and infestations Soft Tissue Infection	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Infections and infestations Skin Infection	4.1% 6/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	10.9% 16/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Infections and infestations Sinusitis	4.1% 6/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	2.7% 4/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Infections and infestations Sepsis	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Infections and infestations Salivary Gland Infection	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Infections and infestations Rash Pustular	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Infections and infestations Peripheral Nerve Infection	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Infections and infestations Papulopustular Rash	2.0% 3/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	1.4% 2/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Infections and infestations Nail Infection	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	1.4% 2/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Infections and infestations Mucosal Infection	2.0% 3/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	1.4% 2/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Infections and infestations Lymph Gland Infection	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Infections and infestations Lung Infection	1.4% 2/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	2.0% 3/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Infections and infestations Eye Infection	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Infections and infestations Device Related Infection	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Infections and infestations Gum Infection	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	1.4% 2/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Infections and infestations Vaginal Infection	2.7% 4/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	1.4% 2/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Infections and infestations Urinary Tract Infection	8.2% 12/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	8.2% 12/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Infections and infestations Catheter Related Infection	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Infections and infestations Joint Infection	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Infections and infestations Bronchial Infection	2.0% 3/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Infections and infestations Bone Infection	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Infections and infestations Bladder Infection	2.0% 3/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Infections and infestations Lip Infection	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	2.0% 3/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Injury, poisoning and procedural complications Wound Dehiscence	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Injury, poisoning and procedural complications Vascular Access Complication	1.4% 2/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Injury, poisoning and procedural complications Vaginal Anastomotic Leak	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Injury, poisoning and procedural complications Urostomy Obstruction	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Injury, poisoning and procedural complications Spinal Fracture	1.4% 2/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Injury, poisoning and procedural complications Radiation Recall Reaction (Dermatologic)	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Injury, poisoning and procedural complications Fracture	2.0% 3/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Injury, poisoning and procedural complications Fall	4.1% 6/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	4.8% 7/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Injury, poisoning and procedural complications Wound Complication	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Blood and lymphatic system disorders Anemia	70.1% 103/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	71.4% 105/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Blood and lymphatic system disorders Febrile Neutropenia	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Cardiac disorders Atrial Fibrillation	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	1.4% 2/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Cardiac disorders Ventricular Tachycardia	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Cardiac disorders Sinus Bradycardia	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	1.4% 2/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Cardiac disorders Palpitations	5.4% 8/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	4.1% 6/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Cardiac disorders Heart Failure	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Cardiac disorders Atrial Flutter	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Cardiac disorders Cardiac Disorders - Other	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Cardiac disorders Pericardial Effusion	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Cardiac disorders Sinus Tachycardia	7.5% 11/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	4.1% 6/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Cardiac disorders Chest Pain - Cardiac	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Ear and labyrinth disorders Middle Ear Inflammation	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Ear and labyrinth disorders Ear And Labyrinth Disorders - Other	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Ear and labyrinth disorders Vertigo	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Ear and labyrinth disorders Tinnitus	2.7% 4/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	3.4% 5/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Ear and labyrinth disorders Hearing Impaired	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	2.7% 4/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Ear and labyrinth disorders Ear Pain	2.0% 3/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Ear and labyrinth disorders External Ear Inflammation	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Endocrine disorders Hyperthyroidism	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Eye disorders Eye Disorders - Other	2.0% 3/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Eye disorders Watering Eyes	1.4% 2/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	1.4% 2/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Eye disorders Flashing Lights	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	1.4% 2/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Eye disorders Eye Pain	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	2.0% 3/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Eye disorders Cataract	2.7% 4/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Eye disorders Conjunctivitis	1.4% 2/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Eye disorders Blurred Vision	4.1% 6/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	3.4% 5/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Eye disorders Dry Eye	2.0% 3/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	1.4% 2/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Eye disorders Floaters	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	1.4% 2/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Gastrointestinal disorders Enterocolitis	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Gastrointestinal disorders Dysphagia	11.6% 17/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	8.2% 12/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Gastrointestinal disorders Dyspepsia	8.8% 13/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	15.0% 22/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Gastrointestinal disorders Duodenal Obstruction	1.4% 2/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Gastrointestinal disorders Dry Mouth	6.8% 10/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	4.8% 7/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Gastrointestinal disorders Colonic Obstruction	2.7% 4/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	1.4% 2/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Gastrointestinal disorders Colitis	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Gastrointestinal disorders Constipation	51.0% 75/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	53.7% 79/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Gastrointestinal disorders Diarrhea	35.4% 52/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	30.6% 45/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Gastrointestinal disorders Cheilitis	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Gastrointestinal disorders Vomiting	32.7% 48/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	47.6% 70/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Gastrointestinal disorders Upper Gastrointestinal Hemorrhage	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Gastrointestinal disorders Bloating	17.7% 26/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	16.3% 24/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Gastrointestinal disorders Small Intestinal Perforation	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Gastrointestinal disorders Stomach Pain	4.8% 7/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	1.4% 2/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Gastrointestinal disorders Small Intestinal Obstruction	8.8% 13/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	8.2% 12/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Gastrointestinal disorders Anal Hemorrhage	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Gastrointestinal disorders Anal Mucositis	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Gastrointestinal disorders Abdominal Pain	36.7% 54/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	41.5% 61/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Gastrointestinal disorders Periodontal Disease	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Gastrointestinal disorders Rectal Hemorrhage	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	2.0% 3/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Gastrointestinal disorders Obstruction Gastric	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Gastrointestinal disorders Small Intestinal Mucositis	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	1.4% 2/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Gastrointestinal disorders Mucositis Oral	38.8% 57/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	38.1% 56/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Gastrointestinal disorders Lower Gastrointestinal Hemorrhage	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Gastrointestinal disorders Gastrointestinal Disorders - Other	2.0% 3/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	3.4% 5/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Gastrointestinal disorders Anal Pain	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Gastrointestinal disorders Oral Hemorrhage	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Gastrointestinal disorders Ileus	2.0% 3/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	3.4% 5/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Gastrointestinal disorders Ileal Obstruction	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Gastrointestinal disorders Gastrointestinal Pain	1.4% 2/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Gastrointestinal disorders Gastric Hemorrhage	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Gastrointestinal disorders Oral Pain	6.8% 10/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	6.8% 10/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Gastrointestinal disorders Abdominal Distension	10.2% 15/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	10.2% 15/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Gastrointestinal disorders Nausea	63.3% 93/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	66.0% 97/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Gastrointestinal disorders Gastroparesis	1.4% 2/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Gastrointestinal disorders Gastric Ulcer	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Gastrointestinal disorders Gastroesophageal Reflux Disease	8.2% 12/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	10.2% 15/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Gastrointestinal disorders Rectal Pain	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Gastrointestinal disorders Lip Pain	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Gastrointestinal disorders Esophageal Ulcer	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Gastrointestinal disorders Esophagitis	4.8% 7/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	1.4% 2/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Gastrointestinal disorders Fecal Incontinence	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Gastrointestinal disorders Hemorrhoidal Hemorrhage	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Gastrointestinal disorders Hemorrhoids	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	2.0% 3/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Gastrointestinal disorders Ascites	10.2% 15/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	5.4% 8/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Gastrointestinal disorders Toothache	2.0% 3/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	2.0% 3/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Gastrointestinal disorders Esophageal Pain	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	3.4% 5/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Gastrointestinal disorders Dental Caries	2.0% 3/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Gastrointestinal disorders Flatulence	4.1% 6/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	4.1% 6/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Gastrointestinal disorders Gastritis	1.4% 2/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	1.4% 2/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
General disorders General Disorders And Administration Site Conditio	2.0% 3/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	4.8% 7/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
General disorders Pain	15.6% 23/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	17.7% 26/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
General disorders Malaise	4.8% 7/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	4.1% 6/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
General disorders Localized Edema	1.4% 2/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
General disorders Irritability	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
General disorders Injection Site Reaction	8.8% 13/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	72.8% 107/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
General disorders Infusion Site Extravasation	1.4% 2/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
General disorders Flu Like Symptoms	5.4% 8/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	30.6% 45/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
General disorders Edema Trunk	1.4% 2/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
General disorders Non-Cardiac Chest Pain	4.1% 6/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	2.0% 3/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Investigations Cd4 Lymphocytes Decreased	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	1.4% 2/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Investigations Blood Bilirubin Increased	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Investigations White Blood Cell Decreased	56.5% 83/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	50.3% 74/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Investigations Aspartate Aminotransferase Increased	9.5% 14/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	11.6% 17/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Investigations Alkaline Phosphatase Increased	12.2% 18/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	12.2% 18/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Investigations Alanine Aminotransferase Increased	8.2% 12/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	6.1% 9/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Investigations Activated Partial Thromboplastin Time Prolonged	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Metabolism and nutrition disorders Metabolism And Nutrition Disorders - Other	2.0% 3/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	1.4% 2/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Metabolism and nutrition disorders Hypophosphatemia	6.8% 10/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	4.1% 6/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Metabolism and nutrition disorders Hyponatremia	12.2% 18/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	14.3% 21/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Metabolism and nutrition disorders Hypomagnesemia	19.0% 28/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	16.3% 24/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Metabolism and nutrition disorders Hypokalemia	19.0% 28/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	8.2% 12/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Metabolism and nutrition disorders Hypoglycemia	4.8% 7/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	1.4% 2/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Metabolism and nutrition disorders Hypocalcemia	9.5% 14/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	10.2% 15/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Metabolism and nutrition disorders Hypoalbuminemia	18.4% 27/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	15.6% 23/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Metabolism and nutrition disorders Hypertriglyceridemia	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	1.4% 2/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Metabolism and nutrition disorders Hypernatremia	3.4% 5/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	1.4% 2/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Metabolism and nutrition disorders Hypermagnesemia	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	1.4% 2/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Metabolism and nutrition disorders Hyperkalemia	5.4% 8/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	2.7% 4/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Metabolism and nutrition disorders Hyperglycemia	19.0% 28/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	12.9% 19/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Metabolism and nutrition disorders Hypercalcemia	2.0% 3/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	2.0% 3/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Metabolism and nutrition disorders Glucose Intolerance	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Metabolism and nutrition disorders Dehydration	6.1% 9/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	7.5% 11/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Metabolism and nutrition disorders Anorexia	31.3% 46/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	32.7% 48/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Metabolism and nutrition disorders Alkalosis	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Musculoskeletal and connective tissue disorders Pain In Extremity	10.2% 15/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	15.6% 23/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Musculoskeletal and connective tissue disorders Osteoporosis	1.4% 2/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Musculoskeletal and connective tissue disorders Neck Pain	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	3.4% 5/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Musculoskeletal and connective tissue disorders Myalgia	16.3% 24/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	13.6% 20/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Musculoskeletal and connective tissue disorders Muscle Weakness Upper Limb	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Musculoskeletal and connective tissue disorders Muscle Weakness Lower Limb	1.4% 2/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	2.0% 3/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Musculoskeletal and connective tissue disorders Muscle Weakness Left-Sided	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Musculoskeletal and connective tissue disorders Joint Range Of Motion Decreased	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Musculoskeletal and connective tissue disorders Joint Effusion	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Musculoskeletal and connective tissue disorders Generalized Muscle Weakness	8.2% 12/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	10.9% 16/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Musculoskeletal and connective tissue disorders Flank Pain	2.0% 3/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	2.0% 3/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Musculoskeletal and connective tissue disorders Chest Wall Pain	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	1.4% 2/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Musculoskeletal and connective tissue disorders Buttock Pain	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	1.4% 2/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Musculoskeletal and connective tissue disorders Bone Pain	5.4% 8/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	4.1% 6/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Musculoskeletal and connective tissue disorders Back Pain	17.7% 26/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	20.4% 30/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Musculoskeletal and connective tissue disorders Avascular Necrosis	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Musculoskeletal and connective tissue disorders Arthritis	2.0% 3/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	2.7% 4/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Musculoskeletal and connective tissue disorders Arthralgia	15.6% 23/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	11.6% 17/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Musculoskeletal and connective tissue disorders Abdominal Soft Tissue Necrosis	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal And Connective Tissue Disorder -	2.7% 4/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	1.4% 2/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms Benign, Malignant And Unspecified (Incl	2.7% 4/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor Pain	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Nervous system disorders Nervous System Disorders - Other	1.4% 2/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Nervous system disorders Tremor	2.0% 3/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	2.0% 3/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Nervous system disorders Transient Ischemic Attacks	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Nervous system disorders Somnolence	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Nervous system disorders Seizure	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Nervous system disorders Presyncope	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	1.4% 2/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Nervous system disorders Peripheral Sensory Neuropathy	32.0% 47/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	30.6% 45/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Nervous system disorders Peripheral Motor Neuropathy	4.1% 6/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	3.4% 5/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Nervous system disorders Paresthesia	3.4% 5/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	4.8% 7/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Nervous system disorders Neuralgia	1.4% 2/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Nervous system disorders Memory Impairment	2.0% 3/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	1.4% 2/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Nervous system disorders Lethargy	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Nervous system disorders Hypersomnia	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Nervous system disorders Headache	23.1% 34/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	18.4% 27/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Nervous system disorders Facial Nerve Disorder	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Nervous system disorders Dysphasia	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Nervous system disorders Dysgeusia	8.8% 13/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	4.8% 7/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Nervous system disorders Dysarthria	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Nervous system disorders Syncope	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Nervous system disorders Dizziness	9.5% 14/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	16.3% 24/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Nervous system disorders Depressed Level Of Consciousness	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Nervous system disorders Concentration Impairment	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Nervous system disorders Cognitive Disturbance	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	2.0% 3/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Nervous system disorders Ataxia	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Nervous system disorders Akathisia	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Psychiatric disorders Psychiatric Disorders - Other	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Psychiatric disorders Suicidal Ideation	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	1.4% 2/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Psychiatric disorders Psychosis	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Psychiatric disorders Insomnia	10.9% 16/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	18.4% 27/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Psychiatric disorders Hallucinations	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Psychiatric disorders Depression	16.3% 24/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	16.3% 24/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Psychiatric disorders Confusion	2.7% 4/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	4.1% 6/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Psychiatric disorders Anxiety	16.3% 24/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	21.8% 32/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Psychiatric disorders Agitation	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	4.1% 6/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Renal and urinary disorders Renal And Urinary Disorders - Other	1.4% 2/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	4.1% 6/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Renal and urinary disorders Urine Discoloration	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Renal and urinary disorders Urinary Urgency	1.4% 2/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	3.4% 5/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Renal and urinary disorders Urinary Tract Obstruction	3.4% 5/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Renal and urinary disorders Urinary Retention	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Renal and urinary disorders Urinary Incontinence	3.4% 5/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	7.5% 11/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Renal and urinary disorders Urinary Tract Pain	2.7% 4/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Renal and urinary disorders Urinary Frequency	4.8% 7/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	8.8% 13/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Renal and urinary disorders Proteinuria	2.0% 3/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Renal and urinary disorders Hemoglobinuria	1.4% 2/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Renal and urinary disorders Hematuria	3.4% 5/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Renal and urinary disorders Chronic Kidney Disease	2.0% 3/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	2.0% 3/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Renal and urinary disorders Acute Kidney Injury	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	1.4% 2/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Reproductive system and breast disorders Reproductive System And Breast Disorders - Other	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Reproductive system and breast disorders Vaginal Pain	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Reproductive system and breast disorders Vaginal Hemorrhage	4.1% 6/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	3.4% 5/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Reproductive system and breast disorders Vaginal Dryness	2.0% 3/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Reproductive system and breast disorders Pelvic Pain	2.7% 4/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	3.4% 5/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Reproductive system and breast disorders Vaginal Discharge	5.4% 8/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	3.4% 5/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Reproductive system and breast disorders Vaginal Inflammation	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Reproductive system and breast disorders Breast Pain	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Respiratory, thoracic and mediastinal disorders Respiratory, Thoracic And Mediastinal Disorders -	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Respiratory, thoracic and mediastinal disorders Sore Throat	4.1% 6/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	4.1% 6/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Respiratory, thoracic and mediastinal disorders Sneezing	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Respiratory, thoracic and mediastinal disorders Sinus Disorder	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	1.4% 2/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Respiratory, thoracic and mediastinal disorders Postnasal Drip	3.4% 5/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	2.7% 4/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	4.8% 7/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	6.1% 9/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal Pain	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Respiratory, thoracic and mediastinal disorders Pharyngeal Mucositis	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Respiratory, thoracic and mediastinal disorders Nasal Congestion	6.8% 10/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	8.2% 12/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Respiratory, thoracic and mediastinal disorders Pleuritic Pain	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	1.4% 2/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Respiratory, thoracic and mediastinal disorders Productive Cough	2.0% 3/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Respiratory, thoracic and mediastinal disorders Hypoxia	2.0% 3/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	1.4% 2/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Respiratory, thoracic and mediastinal disorders Hoarseness	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	1.4% 2/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Respiratory, thoracic and mediastinal disorders Sleep Apnea	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Respiratory, thoracic and mediastinal disorders Hiccups	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	1.4% 2/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Respiratory, thoracic and mediastinal disorders Epistaxis	3.4% 5/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	2.7% 4/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Respiratory, thoracic and mediastinal disorders Dyspnea	27.2% 40/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	26.5% 39/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Respiratory, thoracic and mediastinal disorders Cough	19.7% 29/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	24.5% 36/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Respiratory, thoracic and mediastinal disorders Wheezing	2.0% 3/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Respiratory, thoracic and mediastinal disorders Atelectasis	2.0% 3/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Respiratory, thoracic and mediastinal disorders Allergic Rhinitis	2.0% 3/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	3.4% 5/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Skin and subcutaneous tissue disorders Skin And Subcutaneous Tissue Disorders - Other	5.4% 8/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	10.2% 15/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Skin and subcutaneous tissue disorders Urticaria	1.4% 2/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	2.0% 3/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Skin and subcutaneous tissue disorders Stevens-Johnson Syndrome	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Skin and subcutaneous tissue disorders Skin Ulceration	2.7% 4/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	3.4% 5/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Skin and subcutaneous tissue disorders Skin Induration	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	4.8% 7/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Skin and subcutaneous tissue disorders Skin Hyperpigmentation	13.6% 20/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	14.3% 21/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Skin and subcutaneous tissue disorders Scalp Pain	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Skin and subcutaneous tissue disorders Rash Acneiform	4.8% 7/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	6.1% 9/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Skin and subcutaneous tissue disorders Purpura	1.4% 2/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Skin and subcutaneous tissue disorders Pruritus	16.3% 24/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	13.6% 20/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Skin and subcutaneous tissue disorders Photosensitivity	1.4% 2/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Skin and subcutaneous tissue disorders Palmar-Plantar Erythrodysesthesia Syndrome	37.4% 55/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	36.7% 54/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Skin and subcutaneous tissue disorders Pain Of Skin	4.1% 6/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	2.7% 4/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Skin and subcutaneous tissue disorders Rash Maculo-Papular	39.5% 58/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	36.1% 53/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Skin and subcutaneous tissue disorders Nail Ridging	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	1.4% 2/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Skin and subcutaneous tissue disorders Nail Loss	1.4% 2/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	1.4% 2/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Skin and subcutaneous tissue disorders Nail Discoloration	5.4% 8/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	1.4% 2/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Skin and subcutaneous tissue disorders Hyperhidrosis	2.7% 4/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	2.0% 3/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Skin and subcutaneous tissue disorders Erythema Multiforme	3.4% 5/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	5.4% 8/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Skin and subcutaneous tissue disorders Dry Skin	14.3% 21/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	16.3% 24/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Skin and subcutaneous tissue disorders Bullous Dermatitis	4.1% 6/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	1.4% 2/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Skin and subcutaneous tissue disorders Alopecia	9.5% 14/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	13.6% 20/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Surgical and medical procedures Surgical And Medical Procedures - Other	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	2.0% 3/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Vascular disorders Vascular Disorders - Other	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Vascular disorders Thromboembolic Event	4.8% 7/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	3.4% 5/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Vascular disorders Superficial Thrombophlebitis	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.00% 0/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Vascular disorders Lymphedema	3.4% 5/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	2.7% 4/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Vascular disorders Hypotension	4.1% 6/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	7.5% 11/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Vascular disorders Hypertension	8.8% 13/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	12.2% 18/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Vascular disorders Hot Flashes	8.8% 13/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	4.8% 7/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Vascular disorders Hematoma	2.0% 3/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	2.7% 4/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Vascular disorders Flushing	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.	0.68% 1/147 • Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.

Additional Information

Kristi Manjarrez

Vice President, Clinical Affairs

Phone: 206-689-2256

Email: kmanjarrez@ventirx.com

Results disclosure agreements

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