Trial Outcomes & Findings for A Study of the Safety and Activity of Liposomal Irinotecan in Combination With the 5-FU and Oxaliplatin in the Preoperative Treatment of Pancreatic Adenocarcinoma (NCT NCT03483038)

Last Updated: 2025-09-10

Results Overview

To determine the percentage of subjects who had post-operative complications 30 days post-surgery. Post-operative complications considered for this outcome measure included hospital readmission, death, second surgery or interventional procedure, or major complications extending hospital stay.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

45 participants

Primary outcome timeframe

30 days

Results posted on

2025-09-10

Participant Flow

Participant milestones

Participant milestones
Measure	Liposomal Irinotecan With FOLFOX Subjects will receive 8 cycles and each cycle is 14 days. Liposomal Irinotecan: Subjects will receive 60 mg/m2 intravenously on Day 1 of each 14 day cycle. FOLFOX regimen: Subjects will receive FOLFOX (oxaliplatin 60 mg/m2 IV, leucovorin 400 mg/m2 IV, and 5-fluorouracil 2400 mg/m2 IV) on Day 1 of each 14 day cycle.
Overall Study STARTED	45
Overall Study COMPLETED	27
Overall Study NOT COMPLETED	18

Reasons for withdrawal

Reasons for withdrawal
Measure	Liposomal Irinotecan With FOLFOX Subjects will receive 8 cycles and each cycle is 14 days. Liposomal Irinotecan: Subjects will receive 60 mg/m2 intravenously on Day 1 of each 14 day cycle. FOLFOX regimen: Subjects will receive FOLFOX (oxaliplatin 60 mg/m2 IV, leucovorin 400 mg/m2 IV, and 5-fluorouracil 2400 mg/m2 IV) on Day 1 of each 14 day cycle.
Overall Study Subjects still in follow-up	18

Baseline Characteristics

A Study of the Safety and Activity of Liposomal Irinotecan in Combination With the 5-FU and Oxaliplatin in the Preoperative Treatment of Pancreatic Adenocarcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Liposomal Irinotecan With FOLFOX n=45 Participants Subjects will receive 8 cycles and each cycle is 14 days. Liposomal Irinotecan: Subjects will receive 60 mg/m2 intravenously on Day 1 of each 14 day cycle. FOLFOX regimen: Subjects will receive FOLFOX (oxaliplatin 60 mg/m2 IV, leucovorin 400 mg/m2 IV, and 5-fluorouracil 2400 mg/m2 IV) on Day 1 of each 14 day cycle.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	24 Participants n=5 Participants
Age, Categorical >=65 years	21 Participants n=5 Participants
Age, Continuous	63.133 years n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	43 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants
Race (NIH/OMB) White	40 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	45 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days

Population: The analyzed population for this outcome measure only include those participants who had surgery after completing study treatment with liposomal irinotecan with FOLFOX.

Outcome measures

Outcome measures
Measure	Liposomal Irinotecan With FOLFOX n=29 Participants Subjects will receive 8 cycles and each cycle is 14 days. Liposomal Irinotecan: Subjects will receive 60 mg/m2 intravenously on Day 1 of each 14 day cycle. FOLFOX regimen: Subjects will receive FOLFOX (oxaliplatin 60 mg/m2 IV, leucovorin 400 mg/m2 IV, and 5-fluorouracil 2400 mg/m2 IV) on Day 1 of each 14 day cycle.
Percentage of Subjects Who Had Post-operative Complications 30 Days Post-surgery	10.3 percentage of participants Interval 2.2 to 27.0

SECONDARY outcome

Timeframe: 4 months

To determine the percentage of subjects that completed all eight intended cycles of treatment with liposomal irinotecan with FOLFOX.

Outcome measures

Outcome measures
Measure	Liposomal Irinotecan With FOLFOX n=45 Participants Subjects will receive 8 cycles and each cycle is 14 days. Liposomal Irinotecan: Subjects will receive 60 mg/m2 intravenously on Day 1 of each 14 day cycle. FOLFOX regimen: Subjects will receive FOLFOX (oxaliplatin 60 mg/m2 IV, leucovorin 400 mg/m2 IV, and 5-fluorouracil 2400 mg/m2 IV) on Day 1 of each 14 day cycle.
Percentage of Subjects Who Completed All Intended Cycles of Treatment	73.3 percentage of participants

SECONDARY outcome

Timeframe: 7 months

Population: The analyzed population for this outcome measure only includes those subjects who had surgery after completion of treatment with liposomal irinotecan with FOLFOX.

To determine the percentage of subjects who achieved a complete surgical resection (R0),which is determined from review of pathology reports and inclusive of pathologic nodal status and TNM staging. A complete surgical resection (R0) has been achieved when surgical margins are microscopically negative for residual tumor.

Outcome measures

Outcome measures
Measure	Liposomal Irinotecan With FOLFOX n=29 Participants Subjects will receive 8 cycles and each cycle is 14 days. Liposomal Irinotecan: Subjects will receive 60 mg/m2 intravenously on Day 1 of each 14 day cycle. FOLFOX regimen: Subjects will receive FOLFOX (oxaliplatin 60 mg/m2 IV, leucovorin 400 mg/m2 IV, and 5-fluorouracil 2400 mg/m2 IV) on Day 1 of each 14 day cycle.
Percentage of Subjects Who Achieved a Complete Surgical Resection (R0)	89.7 percentage of participants Interval 72.0 to 97.0

SECONDARY outcome

Timeframe: 5 months

Population: The analyzed population for this outcome measure only includes those participants who were evaluable for this outcome.

To determine the percentage of patients achieving a best overall response of partial or complete response according to RECIST 1.1 criteria from the start of the treatment until disease progression/recurrence. Per RECIST 1.1 criteria, a complete response is the disappearance of all target lesions (any pathological lymph nodes \[whether target or non-target\] must have reduction in short axis to \<10 mm). A partial response is at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters.

Outcome measures

Outcome measures
Measure	Liposomal Irinotecan With FOLFOX n=38 Participants Subjects will receive 8 cycles and each cycle is 14 days. Liposomal Irinotecan: Subjects will receive 60 mg/m2 intravenously on Day 1 of each 14 day cycle. FOLFOX regimen: Subjects will receive FOLFOX (oxaliplatin 60 mg/m2 IV, leucovorin 400 mg/m2 IV, and 5-fluorouracil 2400 mg/m2 IV) on Day 1 of each 14 day cycle.
Percentage of Patients Achieving a Best Overall Response of Partial or Complete Response (Objective Response Rate)	44.7 percentage of participants Interval 29.0 to 62.0

SECONDARY outcome

Timeframe: 9 months

To determine the difference between baseline and maximal nadir of serum CA19-9 level

Outcome measures

Outcome measures
Measure	Liposomal Irinotecan With FOLFOX n=45 Participants Subjects will receive 8 cycles and each cycle is 14 days. Liposomal Irinotecan: Subjects will receive 60 mg/m2 intravenously on Day 1 of each 14 day cycle. FOLFOX regimen: Subjects will receive FOLFOX (oxaliplatin 60 mg/m2 IV, leucovorin 400 mg/m2 IV, and 5-fluorouracil 2400 mg/m2 IV) on Day 1 of each 14 day cycle.
Difference Between Baseline and Maximal Nadir of Serum CA19-9 Level	756.9 units/mL Standard Deviation 2932.7

SECONDARY outcome

Timeframe: Cycles 1, 5, and 8 and at pre-surgical evaluation and post-surgical follow-up visits

Population: The number of participants analyzed for some sub-scores and total scores differs from the overall number of participants due to missing questionnaire responses for some participants.

To determine subject physical, social, emotional, and functional well-being during treatment, as measured by the FACT-G questionnaire. The FACT-G is a 27 item questionnaire where subjects respond to item with a score of 0-4. The responses to the questions are summed to calculate 4 sub-scores: physical well-being (score range 0-28), social well-being (score range: 0-28), emotional well-being (score range: 0-24), and functional well-being (score range: 0-28). The 4 sub-scores are also summed to calculate the total score. Total scores range from 0-108. A higher sub-score or total score indicates better quality of life. Participants completed the FACT-G at Cycles 1, 5, and 8, as well as at the pre-surgical evaluation and follow-up visits.

Outcome measures

Outcome measures
Measure	Liposomal Irinotecan With FOLFOX n=45 Participants Subjects will receive 8 cycles and each cycle is 14 days. Liposomal Irinotecan: Subjects will receive 60 mg/m2 intravenously on Day 1 of each 14 day cycle. FOLFOX regimen: Subjects will receive FOLFOX (oxaliplatin 60 mg/m2 IV, leucovorin 400 mg/m2 IV, and 5-fluorouracil 2400 mg/m2 IV) on Day 1 of each 14 day cycle.
Subject Physical, Social, Emotional, and Functional Well-being During Treatment Physical well-being (Cycle 1)	5.1 score on a scale Standard Deviation 4.8
Subject Physical, Social, Emotional, and Functional Well-being During Treatment Functional well-being (Cycle 1)	19.8 score on a scale Standard Deviation 5
Subject Physical, Social, Emotional, and Functional Well-being During Treatment Total score (Cycle 1)	58.4 score on a scale Standard Deviation 6.6
Subject Physical, Social, Emotional, and Functional Well-being During Treatment Social well-being (Cycle 5)	24.2 score on a scale Standard Deviation 4.2
Subject Physical, Social, Emotional, and Functional Well-being During Treatment Emotional well-being (Cycle 5)	7.4 score on a scale Standard Deviation 4.6
Subject Physical, Social, Emotional, and Functional Well-being During Treatment Functional well-being (Cycle 5)	18.5 score on a scale Standard Deviation 5.9
Subject Physical, Social, Emotional, and Functional Well-being During Treatment Social well-being (Cycle 8)	24.5 score on a scale Standard Deviation 3.9
Subject Physical, Social, Emotional, and Functional Well-being During Treatment Functional well-being (Cycle 8)	18.3 score on a scale Standard Deviation 5.2
Subject Physical, Social, Emotional, and Functional Well-being During Treatment Physical well-being (Pre-surgical evaluation)	5.9 score on a scale Standard Deviation 4.4
Subject Physical, Social, Emotional, and Functional Well-being During Treatment Social well-being (Pre-surgical evaluation)	24.5 score on a scale Standard Deviation 3.7
Subject Physical, Social, Emotional, and Functional Well-being During Treatment Functional well-being (Follow-up)	15.4 score on a scale Standard Deviation 5.9
Subject Physical, Social, Emotional, and Functional Well-being During Treatment Social well-being (Cycle 1)	24.7 score on a scale Standard Deviation 4
Subject Physical, Social, Emotional, and Functional Well-being During Treatment Emotional well-being (Cycle 1)	8.7 score on a scale Standard Deviation 4.3
Subject Physical, Social, Emotional, and Functional Well-being During Treatment Physical well-being (Cycle 5)	8.4 score on a scale Standard Deviation 4.8
Subject Physical, Social, Emotional, and Functional Well-being During Treatment Total score (Cycle 5)	58.5 score on a scale Standard Deviation 9.9
Subject Physical, Social, Emotional, and Functional Well-being During Treatment Physical well-being (Cycle 8)	8.1 score on a scale Standard Deviation 4.9
Subject Physical, Social, Emotional, and Functional Well-being During Treatment Emotional well-being (Cycle 8)	8.3 score on a scale Standard Deviation 4.3
Subject Physical, Social, Emotional, and Functional Well-being During Treatment Total score (Cycle 8)	59.2 score on a scale Standard Deviation 8.3
Subject Physical, Social, Emotional, and Functional Well-being During Treatment Emotional well-being (Pre-surgical evaluation)	8.1 score on a scale Standard Deviation 4
Subject Physical, Social, Emotional, and Functional Well-being During Treatment Functional well-being (Pre-surgical evaluation)	19.1 score on a scale Standard Deviation 5.7
Subject Physical, Social, Emotional, and Functional Well-being During Treatment Total score (Pre-surgical evaluation)	57.6 score on a scale Standard Deviation 8.1
Subject Physical, Social, Emotional, and Functional Well-being During Treatment Physical well-being (Follow-up)	8.5 score on a scale Standard Deviation 5.5
Subject Physical, Social, Emotional, and Functional Well-being During Treatment Social well-being (Follow-up)	24.6 score on a scale Standard Deviation 3.8
Subject Physical, Social, Emotional, and Functional Well-being During Treatment Emotional well-being (Follow-up)	7.8 score on a scale Standard Deviation 4
Subject Physical, Social, Emotional, and Functional Well-being During Treatment Total score (Follow-up)	56.4 score on a scale Standard Deviation 8.1

Adverse Events

Liposomal Irinotecan With FOLFOX

Serious events: 20 serious events

Other events: 45 other events

Deaths: 27 deaths

Serious adverse events

Serious adverse events
Measure	Liposomal Irinotecan With FOLFOX n=45 participants at risk Subjects will receive 8 cycles and each cycle is 14 days. Liposomal Irinotecan: Subjects will receive 60 mg/m2 intravenously on Day 1 of each 14 day cycle. FOLFOX regimen: Subjects will receive FOLFOX (oxaliplatin 60 mg/m2 IV, leucovorin 400 mg/m2 IV, and 5-fluorouracil 2400 mg/m2 IV) on Day 1 of each 14 day cycle.
Renal and urinary disorders Acute kidney injury	4.4% 2/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Investigations Alanine aminotransferase increased	2.2% 1/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Investigations Alkaline phosphatase increased	2.2% 1/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Metabolism and nutrition disorders Anorexia	2.2% 1/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Infections and infestations Appendicitis	2.2% 1/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Investigations Aspartate aminotransferase increased	2.2% 1/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Infections and infestations Biliary tract infection	2.2% 1/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Investigations Blood bilirubin increased	2.2% 1/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Gastrointestinal disorders Colitis	2.2% 1/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Psychiatric disorders Confusion	2.2% 1/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Gastrointestinal disorders Diarrhea	6.7% 3/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Infections and infestations Enterocolitis infectious	2.2% 1/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Injury, poisoning and procedural complications Fall	2.2% 1/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
General disorders Fatigue	4.4% 2/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Blood and lymphatic system disorders Febrile neutropenia	2.2% 1/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
General disorders Fever	2.2% 1/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Gastrointestinal disorders Gastroparesis	2.2% 1/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Vascular disorders Hematoma	2.2% 1/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Metabolism and nutrition disorders Hypokalemia	4.4% 2/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Vascular disorders Hypotension	2.2% 1/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Gastrointestinal disorders Lower gastrointestinal hemorrhage	2.2% 1/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Infections and infestations Lung infection	2.2% 1/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Gastrointestinal disorders Nausea	11.1% 5/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Investigations Neutrophil count decreased	4.4% 2/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Musculoskeletal and connective tissue disorders Pain in extremity	2.2% 1/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Gastrointestinal disorders Pancreatitis	4.4% 2/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Injury, poisoning and procedural complications Postoperative hemorrhage	2.2% 1/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Infections and infestations Sepsis	2.2% 1/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Vascular disorders Thromboembolic event	4.4% 2/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Gastrointestinal disorders Vomiting	4.4% 2/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Infections and infestations Wound infection	2.2% 1/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.

Other adverse events

Other adverse events
Measure	Liposomal Irinotecan With FOLFOX n=45 participants at risk Subjects will receive 8 cycles and each cycle is 14 days. Liposomal Irinotecan: Subjects will receive 60 mg/m2 intravenously on Day 1 of each 14 day cycle. FOLFOX regimen: Subjects will receive FOLFOX (oxaliplatin 60 mg/m2 IV, leucovorin 400 mg/m2 IV, and 5-fluorouracil 2400 mg/m2 IV) on Day 1 of each 14 day cycle.
Gastrointestinal disorders Abdominal distension	2.2% 1/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Gastrointestinal disorders Abdominal pain	48.9% 22/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Psychiatric disorders Agitation	4.4% 2/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Investigations Alanine aminotransferase increased	11.1% 5/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Investigations Alkaline phosphatase increased	8.9% 4/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Immune system disorders Allergic reaction	2.2% 1/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	2.2% 1/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Skin and subcutaneous tissue disorders Alopecia	15.6% 7/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Blood and lymphatic system disorders Anemia	22.2% 10/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Metabolism and nutrition disorders Anorexia	44.4% 20/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Psychiatric disorders Anxiety	17.8% 8/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Investigations Aspartate aminotransferase increased	15.6% 7/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Musculoskeletal and connective tissue disorders Back pain	8.9% 4/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Infections and infestations Biliary tract infection	2.2% 1/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Gastrointestinal disorders Bloating	4.4% 2/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Investigations Blood bilirubin increased	4.4% 2/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Eye disorders Blurred vision	2.2% 1/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Musculoskeletal and connective tissue disorders Bone pain	4.4% 2/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Infections and infestations Bronchial infection	2.2% 1/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Injury, poisoning and procedural complications Bruising	4.4% 2/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Investigations Cardiac troponin I increased	2.2% 1/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Cardiac disorders Chest pain - cardiac	2.2% 1/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
General disorders Chills	8.9% 4/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Gastrointestinal disorders Constipation	31.1% 14/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Respiratory, thoracic and mediastinal disorders Cough	4.4% 2/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Investigations Creatinine increased	2.2% 1/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Metabolism and nutrition disorders Dehydration	17.8% 8/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Psychiatric disorders Depression	8.9% 4/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Gastrointestinal disorders Diarrhea	82.2% 37/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Nervous system disorders Dizziness	15.6% 7/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Gastrointestinal disorders Dry mouth	4.4% 2/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Nervous system disorders Dysgeusia	26.7% 12/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Gastrointestinal disorders Dyspepsia	11.1% 5/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Respiratory, thoracic and mediastinal disorders Dyspnea	11.1% 5/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
General disorders Edema face	2.2% 1/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
General disorders Edema limbs	15.6% 7/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Investigations Electrocardiogram QT corrected interval prolonged	2.2% 1/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Respiratory, thoracic and mediastinal disorders Epistaxis	6.7% 3/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Skin and subcutaneous tissue disorders Erythroderma	2.2% 1/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
General disorders Facial pain	4.4% 2/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
General disorders Fatigue	80.0% 36/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Blood and lymphatic system disorders Febrile neutropenia	2.2% 1/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
General disorders Fever	11.1% 5/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Gastrointestinal disorders Flatulence	2.2% 1/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
General disorders Flu like symptoms	2.2% 1/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Vascular disorders Flushing	2.2% 1/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Gastrointestinal disorders Gastroesophageal reflux disease	4.4% 2/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	4.4% 2/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Nervous system disorders Headache	2.2% 1/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Vascular disorders Hematoma	2.2% 1/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Renal and urinary disorders Hematuria	2.2% 1/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Gastrointestinal disorders Hemorrhoids	2.2% 1/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Respiratory, thoracic and mediastinal disorders Hiccups	6.7% 3/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Metabolism and nutrition disorders Hyperglycemia	15.6% 7/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Vascular disorders Hypertension	11.1% 5/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Metabolism and nutrition disorders Hypoalbuminemia	15.6% 7/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Metabolism and nutrition disorders Hypocalcemia	6.7% 3/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Metabolism and nutrition disorders Hypoglycemia	4.4% 2/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Metabolism and nutrition disorders Hypokalemia	48.9% 22/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Metabolism and nutrition disorders Hypomagnesemia	11.1% 5/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Metabolism and nutrition disorders Hyponatremia	8.9% 4/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Metabolism and nutrition disorders Hypophosphatemia	2.2% 1/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Vascular disorders Hypotension	4.4% 2/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Gastrointestinal disorders Ileus	2.2% 1/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
General disorders Infusion related reaction	6.7% 3/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Psychiatric disorders Insomnia	13.3% 6/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Nervous system disorders Lethargy	2.2% 1/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Investigations Lymphocyte count decreased	11.1% 5/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
General disorders Malaise	4.4% 2/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Infections and infestations Mucosal infection	2.2% 1/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Gastrointestinal disorders Mucositis oral	26.7% 12/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Skin and subcutaneous tissue disorders Nail discoloration	2.2% 1/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Respiratory, thoracic and mediastinal disorders Nasal congestion	2.2% 1/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Gastrointestinal disorders Nausea	86.7% 39/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Investigations Neutrophil count decreased	51.1% 23/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
General disorders Non cardiac chest pain	4.4% 2/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Gastrointestinal disorders Oral dysesthesia	2.2% 1/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Gastrointestinal disorders Oral pain	2.2% 1/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Musculoskeletal and connective tissue disorders Pain in extremity	4.4% 2/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrome	2.2% 1/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Nervous system disorders Paresthesia	26.7% 12/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Nervous system disorders Peripheral motor neuropathy	6.7% 3/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Nervous system disorders Peripheral sensory neuropathy	51.1% 23/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Investigations Platelet count decreased	15.6% 7/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Nervous system disorders Presyncope	2.2% 1/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Skin and subcutaneous tissue disorders Pruritis	4.4% 2/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Skin and subcutaneous tissue disorders Rash maculo-papular	4.4% 2/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Cardiac disorders Sinus tachycardia	6.7% 3/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Infections and infestations Sinusitis	6.7% 3/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Infections and infestations Skin infection	4.4% 2/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Respiratory, thoracic and mediastinal disorders Sore throat	2.2% 1/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Gastrointestinal disorders Stomach pain	4.4% 2/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Vascular disorders Thromboembolic event	11.1% 5/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Renal and urinary disorders Urinary frequency	2.2% 1/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Renal and urinary disorders Urinary tract infection	6.7% 3/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Renal and urinary disorders Urinary tract pain	2.2% 1/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Gastrointestinal disorders Vomiting	37.8% 17/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Investigations Weight loss	24.4% 11/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.
Investigations White blood cell decreased	20.0% 9/45 • Adverse events were collected from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were collected for up to 291 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until either the post-operative visit (if the subject had surgery) or until 30 days after the last dose of study treatment (if the subject did not have surgery). Adverse events were assessed by physical examination, labs, and subject self-reports.

Additional Information

Allison Allegra

University of Florida

Phone: 352-294-5691

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place