Trial Outcomes & Findings for Phase II Study of 5-FU, Oxaliplatin Plus Dasatinib in Metastatic Pancreatic Adenocarcinoma (NCT NCT01652976)

NCT ID: NCT01652976

Last Updated: 2021-01-05

Results Overview

Determine activity of 5-Fluorouracil, leucovorin, and oxaliplatin (FOLFOX) plus dasatinib on progression free survival (PFS) in patients with metastatic pancreatic adenocarcinoma

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 44 participants
• Primary outcome timeframe: 3 years
• Results posted on: 2021-01-05

Participant Flow

Participant milestones

Measure	Dasatinib and mFOLFOX6 Dasatinib and mFOLFOX6 Dasatinib: Dasatinib 150mg PO daily on days 1-14 of each 14 day cycle mFOLFOX6: mFOLFOX6 (oxaliplatin 85mg/m2 IV, leucovorin 400mg/m2 IV, 5-Fluorouracil bolus 400mg/m2 IV, and 5-Fluorouracil 2400mg/m2 IV) on day 1 of each 14 day cycle
Overall Study STARTED	44
Overall Study COMPLETED	44
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phase II Study of 5-FU, Oxaliplatin Plus Dasatinib in Metastatic Pancreatic Adenocarcinoma

Baseline characteristics by cohort

Measure	Treatment Arm n=44 Participants Dasatinib and mFOLFOX6 Dasatinib: Dasatinib 150mg PO daily on days 1-14 of each 14 day cycle mFOLFOX6: mFOLFOX6 (oxaliplatin 85mg/m2 IV, leucovorin 400mg/m2 IV, 5-Fluorouracil bolus 400mg/m2 IV, and 5-Fluorouracil 2400mg/m2 IV) on day 1 of each 14 day cycle
Age, Continuous	65 years n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	29 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 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	4 Participants n=5 Participants
Race (NIH/OMB) White	38 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	44 Participants n=5 Participants
ECOG Performance status Status = 0	22 Participants n=5 Participants
ECOG Performance status Status = 1	19 Participants n=5 Participants
ECOG Performance status Status = 2	2 Participants n=5 Participants
ECOG Performance status Performance Status Unknown	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 years

Determine activity of 5-Fluorouracil, leucovorin, and oxaliplatin (FOLFOX) plus dasatinib on progression free survival (PFS) in patients with metastatic pancreatic adenocarcinoma

Outcome measures

Measure	Dasatinib and mFOLFOX6 n=44 Participants Dasatinib and mFOLFOX6 Dasatinib: Dasatinib 150mg PO daily on days 1-14 of each 14 day cycle mFOLFOX6: mFOLFOX6 (oxaliplatin 85mg/m2 IV, leucovorin 400mg/m2 IV, 5-Fluorouracil bolus 400mg/m2 IV, and 5-Fluorouracil 2400mg/m2 IV) on day 1 of each 14 day cycle
Progression Free Survival (PFS)	4 months Interval 2.3 to 8.5

SECONDARY outcome

Timeframe: 3 years

To determine the response rate (RR) by RECIST 1.1 criteria. The response rate is the number of subjects who had either a complete or partial response by RECIST 1.1 criteria. RECIST 1.1 criteria defines a partial response as a decrease of the sum of the largest diameter each target lesion by at least 30%. A complete response is defined as the disappearance of all target lesions (except lymph nodes, whose short axis must measure 10 mm or less). The imaging modality used for all RECIST assessments in this study was CT.

Outcome measures

Measure	Dasatinib and mFOLFOX6 n=44 Participants Dasatinib and mFOLFOX6 Dasatinib: Dasatinib 150mg PO daily on days 1-14 of each 14 day cycle mFOLFOX6: mFOLFOX6 (oxaliplatin 85mg/m2 IV, leucovorin 400mg/m2 IV, 5-Fluorouracil bolus 400mg/m2 IV, and 5-Fluorouracil 2400mg/m2 IV) on day 1 of each 14 day cycle
Response Rate	25 percentage of subjects Interval 13.19 to 40.34

SECONDARY outcome

Timeframe: 3 years

Population: The number of participants analyzed for this outcome measure only includes the 29 participants who had documented disease progression (by RECIST 1.1 criteria) during study participation.

To determine the rate of freedom from metastasis (FFM), which is defined as the percentage of subjects with documented progressive disease (by RECIST 1.1 criteria) who had no new lesions. RECIST 1.1 criteria defines progressive disease as the appearance of one or more new lesions and/or the increase of the sum of the largest diameter of the target lesions by at least 20% from the smallest sum collected (the sum must also have increased by at least 5 mm).

Outcome measures

Measure	Dasatinib and mFOLFOX6 n=29 Participants Dasatinib and mFOLFOX6 Dasatinib: Dasatinib 150mg PO daily on days 1-14 of each 14 day cycle mFOLFOX6: mFOLFOX6 (oxaliplatin 85mg/m2 IV, leucovorin 400mg/m2 IV, 5-Fluorouracil bolus 400mg/m2 IV, and 5-Fluorouracil 2400mg/m2 IV) on day 1 of each 14 day cycle
Freedom From Metastasis	65.5 percentage of subjects Interval 45.7 to 82.1

SECONDARY outcome

Timeframe: 3 years

Population: The number of participants analyzed for this outcome measure includes only the 11 participants who achieved either a complete or partial response by RECIST 1.1 criteria during study participation.

To determine the median time to progression (TTP). TTP is defined as the time (in months) from when a subject achieves either a complete or partial response by RECIST 1.1 criteria until progressive disease (by RECIST 1.1 criteria) or death occurs.

Outcome measures

Measure	Dasatinib and mFOLFOX6 n=11 Participants Dasatinib and mFOLFOX6 Dasatinib: Dasatinib 150mg PO daily on days 1-14 of each 14 day cycle mFOLFOX6: mFOLFOX6 (oxaliplatin 85mg/m2 IV, leucovorin 400mg/m2 IV, 5-Fluorouracil bolus 400mg/m2 IV, and 5-Fluorouracil 2400mg/m2 IV) on day 1 of each 14 day cycle
Median Time To Progression	9.8 months Interval 8.6 to 19.5

SECONDARY outcome

Timeframe: 4 years

To determine median overall survival (OS) in months

Outcome measures

Measure	Dasatinib and mFOLFOX6 n=44 Participants Dasatinib and mFOLFOX6 Dasatinib: Dasatinib 150mg PO daily on days 1-14 of each 14 day cycle mFOLFOX6: mFOLFOX6 (oxaliplatin 85mg/m2 IV, leucovorin 400mg/m2 IV, 5-Fluorouracil bolus 400mg/m2 IV, and 5-Fluorouracil 2400mg/m2 IV) on day 1 of each 14 day cycle
Median Overall Survival	10.6 months Interval 6.9 to 12.7

SECONDARY outcome

Timeframe: 3 years

To determine the clinical benefit rate (CBR). The CBR is defined as the percentage of subjects who achieved either a complete or partial response or stable disease by RECIST 1.1 criteria. RECIST 1.1 criteria defines a partial response as a decrease of the sum of the largest diameter each target lesion by at least 30%. A complete response is defined as the disappearance of all target lesions (except lymph nodes, whose short axis must measure 10 mm or less). By RECIST 1.1 criteria, a subject is considered to have stable disease when the sum of the largest diameter of the target lesions has neither decreased enough to qualify as a partial response not increased enough to qualify as progressive disease.

Outcome measures

Measure	Dasatinib and mFOLFOX6 n=44 Participants Dasatinib and mFOLFOX6 Dasatinib: Dasatinib 150mg PO daily on days 1-14 of each 14 day cycle mFOLFOX6: mFOLFOX6 (oxaliplatin 85mg/m2 IV, leucovorin 400mg/m2 IV, 5-Fluorouracil bolus 400mg/m2 IV, and 5-Fluorouracil 2400mg/m2 IV) on day 1 of each 14 day cycle
Clinical Benefit Rate	56.82 percentage of subjects Interval 41.03 to 71.65

SECONDARY outcome

Timeframe: 3 years

To determine the site of failure of this regimen in this population. The site of failure is the anatomical site(s) where disease progression by RECIST 1.1 criteria was noted on imaging.

Outcome measures

Measure	Dasatinib and mFOLFOX6 n=44 Participants Dasatinib and mFOLFOX6 Dasatinib: Dasatinib 150mg PO daily on days 1-14 of each 14 day cycle mFOLFOX6: mFOLFOX6 (oxaliplatin 85mg/m2 IV, leucovorin 400mg/m2 IV, 5-Fluorouracil bolus 400mg/m2 IV, and 5-Fluorouracil 2400mg/m2 IV) on day 1 of each 14 day cycle
Site of Failure Left pleural effusion	1 Participants
Site of Failure Liver	12 Participants
Site of Failure Lungs	3 Participants
Site of Failure Pancreas/liver	4 Participants
Site of Failure Peritoneal carcinomatosis	1 Participants
Site of Failure peritoneal carcinomatosis/liver	1 Participants
Site of Failure Spleen/liver	1 Participants

SECONDARY outcome

Timeframe: 3 years

To determine the safety profile and tolerability of this regimen in this population by evaluating acute treatment related toxicities using CTCAE v4.0 criteria. Using the CTCAE v4.0, the severity of each adverse event reported was graded on a scale of 1 (mild severity) to 5 (fatal). For this outcome measure the percentage of subjects experiencing any adverse event of each CTCAE grade was tabulated.

Outcome measures

Measure	Dasatinib and mFOLFOX6 n=44 Participants Dasatinib and mFOLFOX6 Dasatinib: Dasatinib 150mg PO daily on days 1-14 of each 14 day cycle mFOLFOX6: mFOLFOX6 (oxaliplatin 85mg/m2 IV, leucovorin 400mg/m2 IV, 5-Fluorouracil bolus 400mg/m2 IV, and 5-Fluorouracil 2400mg/m2 IV) on day 1 of each 14 day cycle
Safety and Tolerability Percent of subjects experiencing a Grade 1 event	88.6 percentage of subjects
Safety and Tolerability Percent of subjects experiencing a grade 2 event	90.9 percentage of subjects
Safety and Tolerability Percent of subjects experiencing a Grade 3 event	86.4 percentage of subjects
Safety and Tolerability Percent of subjects experiencing a Grade 4 event	22.7 percentage of subjects
Safety and Tolerability Percent of subjects experiencing a grade 5 event	9.1 percentage of subjects

SECONDARY outcome

Timeframe: 3 years

To determine patient compliance with oral therapy. For this outcome measure, compliance with oral therapy is defined as the percentage of subjects that took dasatinib for at least one cycle. Compliance with oral therapy was documented with a medication diary that subjects were asked to complete to document whether each dose of dasatinib was taken.

Outcome measures

Measure	Dasatinib and mFOLFOX6 n=44 Participants Dasatinib and mFOLFOX6 Dasatinib: Dasatinib 150mg PO daily on days 1-14 of each 14 day cycle mFOLFOX6: mFOLFOX6 (oxaliplatin 85mg/m2 IV, leucovorin 400mg/m2 IV, 5-Fluorouracil bolus 400mg/m2 IV, and 5-Fluorouracil 2400mg/m2 IV) on day 1 of each 14 day cycle
Drug Compliance	93.2 percentage of subjects Interval 81.3 to 98.6

SECONDARY outcome

Timeframe: 3 years

To determine the quality of life (QOL) of patients receiving this therapy using the CTSQ questionnaire. The CTSQ consists of 16 questions where subjects respond with a score on a scale of 0 (worst)-4 (best). The responses to the questions are used to calculate 3 subscores: Expectations of Therapy (ET), Feelings about Side Effects (FSE), and Satisfaction with Therapy (SWT). Each subscore is calculated by multiplying the mean response value for the questions used to calculate that subscore by 25. The maximum value is 100 and the minimum value is 0 for all 3 subscores. A higher subscore indicates better QOL in that area. The mean difference in each of the 3 subscores from baseline and 95% confidence interval for the entire study population is reported here. A negative mean difference indicates a decrease from baseline in QOL for that area.

Outcome measures

Measure	Dasatinib and mFOLFOX6 n=44 Participants Dasatinib and mFOLFOX6 Dasatinib: Dasatinib 150mg PO daily on days 1-14 of each 14 day cycle mFOLFOX6: mFOLFOX6 (oxaliplatin 85mg/m2 IV, leucovorin 400mg/m2 IV, 5-Fluorouracil bolus 400mg/m2 IV, and 5-Fluorouracil 2400mg/m2 IV) on day 1 of each 14 day cycle
Quality of Life, as Measured by the Cancer Therapy Satisfaction Questionnaire (CTSQ), 2007 Subscore difference for ET	-8.4 score on a scale Interval -16.5 to -0.4
Quality of Life, as Measured by the Cancer Therapy Satisfaction Questionnaire (CTSQ), 2007 Subscore difference for FSE	2.1 score on a scale Interval -8.1 to 12.3
Quality of Life, as Measured by the Cancer Therapy Satisfaction Questionnaire (CTSQ), 2007 Subscore difference for SWT	-0.5 score on a scale Interval -8.8 to 7.8

SECONDARY outcome

Timeframe: 3 years

The FACT-Hep consists of 45 questions where subjects respond with a score on a scale of 0 (worst)-4 (best). The responses to the questions are summed to calculate 5 subscores: Physical Well-Being (PWB), Social Well-Being (SWB), Emotional Well-Being (EWB), Functional Well-Being (FWB), and Hepatobiliary Cancer Subscale (HCS). The mean difference in each of the 5 subscores from baseline, as well as the total score of the 5 subscores (the FACT-Hep Total Score) for the entire study population is reported here. The mean difference in the FACT-G Total Score (calculated by summing the PWB, SWB, EWB, and FWB subscores) is also reported here. A negative mean difference indicates a decrease from baseline in QOL. Score ranges- PWB subscore: 0-28, SWB subscore: 0-28, EWB subscore: 0-24, FWB subscore: 0-28, HCS subscore: 0-72, FACT-G Total Score: 0-108, and FACT-Hep Total Score: 0-180. A higher value for each subscore or total score indicates better QOL.

Outcome measures

Measure	Dasatinib and mFOLFOX6 n=44 Participants Dasatinib and mFOLFOX6 Dasatinib: Dasatinib 150mg PO daily on days 1-14 of each 14 day cycle mFOLFOX6: mFOLFOX6 (oxaliplatin 85mg/m2 IV, leucovorin 400mg/m2 IV, 5-Fluorouracil bolus 400mg/m2 IV, and 5-Fluorouracil 2400mg/m2 IV) on day 1 of each 14 day cycle
Quality of Life, as Measured by the Functional Assessment of Chronic Illness Therapy; Hepatobiliary Cancer (FACT-Hep) Questionnaire (Version 4.0) Subscore difference for PWB	-4.4 score on a scale Interval -6.7 to -2.1
Quality of Life, as Measured by the Functional Assessment of Chronic Illness Therapy; Hepatobiliary Cancer (FACT-Hep) Questionnaire (Version 4.0) Subscore difference for SWB	-0.9 score on a scale Interval -2.5 to 0.8
Quality of Life, as Measured by the Functional Assessment of Chronic Illness Therapy; Hepatobiliary Cancer (FACT-Hep) Questionnaire (Version 4.0) Subscore difference for EWB	0.6 score on a scale Interval -1.1 to 2.3
Quality of Life, as Measured by the Functional Assessment of Chronic Illness Therapy; Hepatobiliary Cancer (FACT-Hep) Questionnaire (Version 4.0) Subscore difference for FWB	-2.8 score on a scale Interval -4.6 to -1.0
Quality of Life, as Measured by the Functional Assessment of Chronic Illness Therapy; Hepatobiliary Cancer (FACT-Hep) Questionnaire (Version 4.0) Subscore difference for HCS	-6.3 score on a scale Interval -9.3 to -3.4
Quality of Life, as Measured by the Functional Assessment of Chronic Illness Therapy; Hepatobiliary Cancer (FACT-Hep) Questionnaire (Version 4.0) Difference in FACT-G Total Score	-7.4 score on a scale Interval -11.9 to -2.9
Quality of Life, as Measured by the Functional Assessment of Chronic Illness Therapy; Hepatobiliary Cancer (FACT-Hep) Questionnaire (Version 4.0) Difference in FACT-Hep Total Score	-13.7 score on a scale Interval -20.0 to -7.4

Adverse Events

Treatment Arm

Serious events: 24 serious events

Other events: 44 other events

Deaths: 42 deaths

Serious adverse events

Measure	Treatment Arm n=44 participants at risk Dasatinib and mFOLFOX6 Dasatinib: Dasatinib 150mg PO daily on days 1-14 of each 14 day cycle mFOLFOX6: mFOLFOX6 (oxaliplatin 85mg/m2 IV, leucovorin 400mg/m2 IV, 5-Fluorouracil bolus 400mg/m2 IV, and 5-Fluorouracil 2400mg/m2 IV) on day 1 of each 14 day cycle
Nervous system disorders Nervous system disorders, other (Stroke-like symptoms)	2.3% 1/44 • Adverse event data were collected from the time that informed consent was signed until 30 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. The time over which adverse event data was collected for the subjects ranged from 8 days to 44 months, an average of 8.5 months. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Respiratory, thoracic and mediastinal disorders Pleural effusion	9.1% 4/44 • Adverse event data were collected from the time that informed consent was signed until 30 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. The time over which adverse event data was collected for the subjects ranged from 8 days to 44 months, an average of 8.5 months. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Gastrointestinal disorders Gastritis	2.3% 1/44 • Adverse event data were collected from the time that informed consent was signed until 30 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. The time over which adverse event data was collected for the subjects ranged from 8 days to 44 months, an average of 8.5 months. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Gastrointestinal disorders Abdominal pain	4.5% 2/44 • Adverse event data were collected from the time that informed consent was signed until 30 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. The time over which adverse event data was collected for the subjects ranged from 8 days to 44 months, an average of 8.5 months. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Blood and lymphatic system disorders Febrile neutropenia	4.5% 2/44 • Adverse event data were collected from the time that informed consent was signed until 30 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. The time over which adverse event data was collected for the subjects ranged from 8 days to 44 months, an average of 8.5 months. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Respiratory, thoracic and mediastinal disorders Upper respiratory infection	2.3% 1/44 • Adverse event data were collected from the time that informed consent was signed until 30 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. The time over which adverse event data was collected for the subjects ranged from 8 days to 44 months, an average of 8.5 months. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Investigations Blood bilirubin increased	2.3% 1/44 • Adverse event data were collected from the time that informed consent was signed until 30 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. The time over which adverse event data was collected for the subjects ranged from 8 days to 44 months, an average of 8.5 months. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Gastrointestinal disorders Gastrointestinal disorders, other (gastrointestinal hemorrhage-unknown site)	2.3% 1/44 • Adverse event data were collected from the time that informed consent was signed until 30 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. The time over which adverse event data was collected for the subjects ranged from 8 days to 44 months, an average of 8.5 months. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Gastrointestinal disorders Abdominal infection	2.3% 1/44 • Adverse event data were collected from the time that informed consent was signed until 30 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. The time over which adverse event data was collected for the subjects ranged from 8 days to 44 months, an average of 8.5 months. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Renal and urinary disorders Renal and urinary disorders, other (kidney stone)	2.3% 1/44 • Adverse event data were collected from the time that informed consent was signed until 30 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. The time over which adverse event data was collected for the subjects ranged from 8 days to 44 months, an average of 8.5 months. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
General disorders Non-cardiac chest pain	2.3% 1/44 • Adverse event data were collected from the time that informed consent was signed until 30 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. The time over which adverse event data was collected for the subjects ranged from 8 days to 44 months, an average of 8.5 months. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Respiratory, thoracic and mediastinal disorders Respiratory failure	2.3% 1/44 • Adverse event data were collected from the time that informed consent was signed until 30 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. The time over which adverse event data was collected for the subjects ranged from 8 days to 44 months, an average of 8.5 months. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Cardiac disorders Atrial fibrillation	2.3% 1/44 • Adverse event data were collected from the time that informed consent was signed until 30 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. The time over which adverse event data was collected for the subjects ranged from 8 days to 44 months, an average of 8.5 months. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
General disorders Fever	2.3% 1/44 • Adverse event data were collected from the time that informed consent was signed until 30 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. The time over which adverse event data was collected for the subjects ranged from 8 days to 44 months, an average of 8.5 months. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Gastrointestinal disorders Diarrhea	2.3% 1/44 • Adverse event data were collected from the time that informed consent was signed until 30 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. The time over which adverse event data was collected for the subjects ranged from 8 days to 44 months, an average of 8.5 months. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Metabolism and nutrition disorders Hypercalcemia	2.3% 1/44 • Adverse event data were collected from the time that informed consent was signed until 30 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. The time over which adverse event data was collected for the subjects ranged from 8 days to 44 months, an average of 8.5 months. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Renal and urinary disorders Acute renal injury	2.3% 1/44 • Adverse event data were collected from the time that informed consent was signed until 30 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. The time over which adverse event data was collected for the subjects ranged from 8 days to 44 months, an average of 8.5 months. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
General disorders Flu-like symptoms	2.3% 1/44 • Adverse event data were collected from the time that informed consent was signed until 30 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. The time over which adverse event data was collected for the subjects ranged from 8 days to 44 months, an average of 8.5 months. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Gastrointestinal disorders Nausea	6.8% 3/44 • Adverse event data were collected from the time that informed consent was signed until 30 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. The time over which adverse event data was collected for the subjects ranged from 8 days to 44 months, an average of 8.5 months. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Gastrointestinal disorders Vomiting	6.8% 3/44 • Adverse event data were collected from the time that informed consent was signed until 30 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. The time over which adverse event data was collected for the subjects ranged from 8 days to 44 months, an average of 8.5 months. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Gastrointestinal disorders Small intestinal obstruction	2.3% 1/44 • Adverse event data were collected from the time that informed consent was signed until 30 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. The time over which adverse event data was collected for the subjects ranged from 8 days to 44 months, an average of 8.5 months. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Nervous system disorders Subdural hematoma	2.3% 1/44 • Adverse event data were collected from the time that informed consent was signed until 30 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. The time over which adverse event data was collected for the subjects ranged from 8 days to 44 months, an average of 8.5 months. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Gastrointestinal disorders Ascites	2.3% 1/44 • Adverse event data were collected from the time that informed consent was signed until 30 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. The time over which adverse event data was collected for the subjects ranged from 8 days to 44 months, an average of 8.5 months. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Metabolism and nutrition disorders Dehydration	2.3% 1/44 • Adverse event data were collected from the time that informed consent was signed until 30 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. The time over which adverse event data was collected for the subjects ranged from 8 days to 44 months, an average of 8.5 months. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Gastrointestinal disorders Lower gastrointestinal hemorrhage	2.3% 1/44 • Adverse event data were collected from the time that informed consent was signed until 30 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. The time over which adverse event data was collected for the subjects ranged from 8 days to 44 months, an average of 8.5 months. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Gastrointestinal disorders Cholangitis	2.3% 1/44 • Adverse event data were collected from the time that informed consent was signed until 30 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. The time over which adverse event data was collected for the subjects ranged from 8 days to 44 months, an average of 8.5 months. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Gastrointestinal disorders Colitis	2.3% 1/44 • Adverse event data were collected from the time that informed consent was signed until 30 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. The time over which adverse event data was collected for the subjects ranged from 8 days to 44 months, an average of 8.5 months. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic, and mediastinal disorders, other (pneumonia)	2.3% 1/44 • Adverse event data were collected from the time that informed consent was signed until 30 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. The time over which adverse event data was collected for the subjects ranged from 8 days to 44 months, an average of 8.5 months. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Gastrointestinal disorders Esophageal infection	2.3% 1/44 • Adverse event data were collected from the time that informed consent was signed until 30 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. The time over which adverse event data was collected for the subjects ranged from 8 days to 44 months, an average of 8.5 months. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Gastrointestinal disorders Oral Mucositis	2.3% 1/44 • Adverse event data were collected from the time that informed consent was signed until 30 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. The time over which adverse event data was collected for the subjects ranged from 8 days to 44 months, an average of 8.5 months. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Infections and infestations Sepsis	2.3% 1/44 • Adverse event data were collected from the time that informed consent was signed until 30 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. The time over which adverse event data was collected for the subjects ranged from 8 days to 44 months, an average of 8.5 months. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Injury, poisoning and procedural complications Wound dehiscense	2.3% 1/44 • Adverse event data were collected from the time that informed consent was signed until 30 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. The time over which adverse event data was collected for the subjects ranged from 8 days to 44 months, an average of 8.5 months. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
General disorders Edema trunk	2.3% 1/44 • Adverse event data were collected from the time that informed consent was signed until 30 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. The time over which adverse event data was collected for the subjects ranged from 8 days to 44 months, an average of 8.5 months. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.

Other adverse events

Measure	Treatment Arm n=44 participants at risk Dasatinib and mFOLFOX6 Dasatinib: Dasatinib 150mg PO daily on days 1-14 of each 14 day cycle mFOLFOX6: mFOLFOX6 (oxaliplatin 85mg/m2 IV, leucovorin 400mg/m2 IV, 5-Fluorouracil bolus 400mg/m2 IV, and 5-Fluorouracil 2400mg/m2 IV) on day 1 of each 14 day cycle
Gastrointestinal disorders Vomiting	59.1% 26/44 • Adverse event data were collected from the time that informed consent was signed until 30 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. The time over which adverse event data was collected for the subjects ranged from 8 days to 44 months, an average of 8.5 months. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Renal and urinary disorders Urinary frequency	9.1% 4/44 • Adverse event data were collected from the time that informed consent was signed until 30 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. The time over which adverse event data was collected for the subjects ranged from 8 days to 44 months, an average of 8.5 months. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Infections and infestations Upper respiratory tract infection	15.9% 7/44 • Adverse event data were collected from the time that informed consent was signed until 30 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. The time over which adverse event data was collected for the subjects ranged from 8 days to 44 months, an average of 8.5 months. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Respiratory, thoracic and mediastinal disorders Sore throat	6.8% 3/44 • Adverse event data were collected from the time that informed consent was signed until 30 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. The time over which adverse event data was collected for the subjects ranged from 8 days to 44 months, an average of 8.5 months. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Skin and subcutaneous tissue disorders Skin and subcutaneous disorders, other	11.4% 5/44 • Adverse event data were collected from the time that informed consent was signed until 30 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. The time over which adverse event data was collected for the subjects ranged from 8 days to 44 months, an average of 8.5 months. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Investigations Weight Loss	25.0% 11/44 • Adverse event data were collected from the time that informed consent was signed until 30 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. The time over which adverse event data was collected for the subjects ranged from 8 days to 44 months, an average of 8.5 months. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Skin and subcutaneous tissue disorders Rash maculo-papular	15.9% 7/44 • Adverse event data were collected from the time that informed consent was signed until 30 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. The time over which adverse event data was collected for the subjects ranged from 8 days to 44 months, an average of 8.5 months. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Respiratory, thoracic and mediastinal disorders Pleural effusion	20.5% 9/44 • Adverse event data were collected from the time that informed consent was signed until 30 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. The time over which adverse event data was collected for the subjects ranged from 8 days to 44 months, an average of 8.5 months. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Investigations Platelet count decreased	18.2% 8/44 • Adverse event data were collected from the time that informed consent was signed until 30 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. The time over which adverse event data was collected for the subjects ranged from 8 days to 44 months, an average of 8.5 months. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Nervous system disorders Peripheral sensory Neuropathy	68.2% 30/44 • Adverse event data were collected from the time that informed consent was signed until 30 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. The time over which adverse event data was collected for the subjects ranged from 8 days to 44 months, an average of 8.5 months. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Skin and subcutaneous tissue disorders Periorbital edema	13.6% 6/44 • Adverse event data were collected from the time that informed consent was signed until 30 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. The time over which adverse event data was collected for the subjects ranged from 8 days to 44 months, an average of 8.5 months. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Nervous system disorders Parasthesia	6.8% 3/44 • Adverse event data were collected from the time that informed consent was signed until 30 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. The time over which adverse event data was collected for the subjects ranged from 8 days to 44 months, an average of 8.5 months. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrome	6.8% 3/44 • Adverse event data were collected from the time that informed consent was signed until 30 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. The time over which adverse event data was collected for the subjects ranged from 8 days to 44 months, an average of 8.5 months. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Musculoskeletal and connective tissue disorders Pain in extremity	6.8% 3/44 • Adverse event data were collected from the time that informed consent was signed until 30 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. The time over which adverse event data was collected for the subjects ranged from 8 days to 44 months, an average of 8.5 months. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
General disorders Pain	6.8% 3/44 • Adverse event data were collected from the time that informed consent was signed until 30 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. The time over which adverse event data was collected for the subjects ranged from 8 days to 44 months, an average of 8.5 months. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Gastrointestinal disorders Oral Pain	11.4% 5/44 • Adverse event data were collected from the time that informed consent was signed until 30 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. The time over which adverse event data was collected for the subjects ranged from 8 days to 44 months, an average of 8.5 months. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Investigations Neutrophil count decreased	34.1% 15/44 • Adverse event data were collected from the time that informed consent was signed until 30 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. The time over which adverse event data was collected for the subjects ranged from 8 days to 44 months, an average of 8.5 months. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Gastrointestinal disorders Nausea	70.5% 31/44 • Adverse event data were collected from the time that informed consent was signed until 30 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. The time over which adverse event data was collected for the subjects ranged from 8 days to 44 months, an average of 8.5 months. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Gastrointestinal disorders Mucositis oral	38.6% 17/44 • Adverse event data were collected from the time that informed consent was signed until 30 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. The time over which adverse event data was collected for the subjects ranged from 8 days to 44 months, an average of 8.5 months. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
General disorders Localized edema	6.8% 3/44 • Adverse event data were collected from the time that informed consent was signed until 30 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. The time over which adverse event data was collected for the subjects ranged from 8 days to 44 months, an average of 8.5 months. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Psychiatric disorders Insomnia	18.2% 8/44 • Adverse event data were collected from the time that informed consent was signed until 30 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. The time over which adverse event data was collected for the subjects ranged from 8 days to 44 months, an average of 8.5 months. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Metabolism and nutrition disorders Hyponatremia	9.1% 4/44 • Adverse event data were collected from the time that informed consent was signed until 30 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. The time over which adverse event data was collected for the subjects ranged from 8 days to 44 months, an average of 8.5 months. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Metabolism and nutrition disorders Hypokalemia	9.1% 4/44 • Adverse event data were collected from the time that informed consent was signed until 30 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. The time over which adverse event data was collected for the subjects ranged from 8 days to 44 months, an average of 8.5 months. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Vascular disorders Hypertension	9.1% 4/44 • Adverse event data were collected from the time that informed consent was signed until 30 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. The time over which adverse event data was collected for the subjects ranged from 8 days to 44 months, an average of 8.5 months. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Respiratory, thoracic and mediastinal disorders Hiccups	9.1% 4/44 • Adverse event data were collected from the time that informed consent was signed until 30 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. The time over which adverse event data was collected for the subjects ranged from 8 days to 44 months, an average of 8.5 months. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Gastrointestinal disorders Hemorrhoids	6.8% 3/44 • Adverse event data were collected from the time that informed consent was signed until 30 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. The time over which adverse event data was collected for the subjects ranged from 8 days to 44 months, an average of 8.5 months. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Nervous system disorders Headache	13.6% 6/44 • Adverse event data were collected from the time that informed consent was signed until 30 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. The time over which adverse event data was collected for the subjects ranged from 8 days to 44 months, an average of 8.5 months. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
General disorders General disorders and administrative site conditions - other	6.8% 3/44 • Adverse event data were collected from the time that informed consent was signed until 30 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. The time over which adverse event data was collected for the subjects ranged from 8 days to 44 months, an average of 8.5 months. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Gastrointestinal disorders Gastroesophageal reflux disease	6.8% 3/44 • Adverse event data were collected from the time that informed consent was signed until 30 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. The time over which adverse event data was collected for the subjects ranged from 8 days to 44 months, an average of 8.5 months. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
General disorders Flu-like symtoms	9.1% 4/44 • Adverse event data were collected from the time that informed consent was signed until 30 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. The time over which adverse event data was collected for the subjects ranged from 8 days to 44 months, an average of 8.5 months. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
General disorders Fever	25.0% 11/44 • Adverse event data were collected from the time that informed consent was signed until 30 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. The time over which adverse event data was collected for the subjects ranged from 8 days to 44 months, an average of 8.5 months. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
General disorders Fatigue	72.7% 32/44 • Adverse event data were collected from the time that informed consent was signed until 30 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. The time over which adverse event data was collected for the subjects ranged from 8 days to 44 months, an average of 8.5 months. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Injury, poisoning and procedural complications Fall	6.8% 3/44 • Adverse event data were collected from the time that informed consent was signed until 30 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. The time over which adverse event data was collected for the subjects ranged from 8 days to 44 months, an average of 8.5 months. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Respiratory, thoracic and mediastinal disorders Epistaxis	9.1% 4/44 • Adverse event data were collected from the time that informed consent was signed until 30 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. The time over which adverse event data was collected for the subjects ranged from 8 days to 44 months, an average of 8.5 months. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
General disorders Edema limbs	15.9% 7/44 • Adverse event data were collected from the time that informed consent was signed until 30 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. The time over which adverse event data was collected for the subjects ranged from 8 days to 44 months, an average of 8.5 months. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Respiratory, thoracic and mediastinal disorders Dyspnea	20.5% 9/44 • Adverse event data were collected from the time that informed consent was signed until 30 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. The time over which adverse event data was collected for the subjects ranged from 8 days to 44 months, an average of 8.5 months. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Nervous system disorders Dysgeusia	27.3% 12/44 • Adverse event data were collected from the time that informed consent was signed until 30 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. The time over which adverse event data was collected for the subjects ranged from 8 days to 44 months, an average of 8.5 months. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Nervous system disorders Dysethesia	6.8% 3/44 • Adverse event data were collected from the time that informed consent was signed until 30 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. The time over which adverse event data was collected for the subjects ranged from 8 days to 44 months, an average of 8.5 months. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Nervous system disorders Dizziness	15.9% 7/44 • Adverse event data were collected from the time that informed consent was signed until 30 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. The time over which adverse event data was collected for the subjects ranged from 8 days to 44 months, an average of 8.5 months. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Gastrointestinal disorders Diarrhea	54.5% 24/44 • Adverse event data were collected from the time that informed consent was signed until 30 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. The time over which adverse event data was collected for the subjects ranged from 8 days to 44 months, an average of 8.5 months. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Psychiatric disorders Depression	9.1% 4/44 • Adverse event data were collected from the time that informed consent was signed until 30 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. The time over which adverse event data was collected for the subjects ranged from 8 days to 44 months, an average of 8.5 months. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Metabolism and nutrition disorders Dehydration	9.1% 4/44 • Adverse event data were collected from the time that informed consent was signed until 30 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. The time over which adverse event data was collected for the subjects ranged from 8 days to 44 months, an average of 8.5 months. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Respiratory, thoracic and mediastinal disorders Cough	6.8% 3/44 • Adverse event data were collected from the time that informed consent was signed until 30 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. The time over which adverse event data was collected for the subjects ranged from 8 days to 44 months, an average of 8.5 months. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Gastrointestinal disorders Constipation	43.2% 19/44 • Adverse event data were collected from the time that informed consent was signed until 30 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. The time over which adverse event data was collected for the subjects ranged from 8 days to 44 months, an average of 8.5 months. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
General disorders Chills	11.4% 5/44 • Adverse event data were collected from the time that informed consent was signed until 30 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. The time over which adverse event data was collected for the subjects ranged from 8 days to 44 months, an average of 8.5 months. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Gastrointestinal disorders Bloating	9.1% 4/44 • Adverse event data were collected from the time that informed consent was signed until 30 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. The time over which adverse event data was collected for the subjects ranged from 8 days to 44 months, an average of 8.5 months. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Musculoskeletal and connective tissue disorders Back Pain	11.4% 5/44 • Adverse event data were collected from the time that informed consent was signed until 30 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. The time over which adverse event data was collected for the subjects ranged from 8 days to 44 months, an average of 8.5 months. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Gastrointestinal disorders Ascites	11.4% 5/44 • Adverse event data were collected from the time that informed consent was signed until 30 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. The time over which adverse event data was collected for the subjects ranged from 8 days to 44 months, an average of 8.5 months. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Psychiatric disorders Anxiety	20.5% 9/44 • Adverse event data were collected from the time that informed consent was signed until 30 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. The time over which adverse event data was collected for the subjects ranged from 8 days to 44 months, an average of 8.5 months. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Metabolism and nutrition disorders Anorexia	47.7% 21/44 • Adverse event data were collected from the time that informed consent was signed until 30 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. The time over which adverse event data was collected for the subjects ranged from 8 days to 44 months, an average of 8.5 months. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Blood and lymphatic system disorders Anemia	20.5% 9/44 • Adverse event data were collected from the time that informed consent was signed until 30 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. The time over which adverse event data was collected for the subjects ranged from 8 days to 44 months, an average of 8.5 months. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Gastrointestinal disorders Abdominal distension	9.1% 4/44 • Adverse event data were collected from the time that informed consent was signed until 30 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. The time over which adverse event data was collected for the subjects ranged from 8 days to 44 months, an average of 8.5 months. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Gastrointestinal disorders Abdominal pain	40.9% 18/44 • Adverse event data were collected from the time that informed consent was signed until 30 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. The time over which adverse event data was collected for the subjects ranged from 8 days to 44 months, an average of 8.5 months. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.

Additional Information

Allison Allegra

University of Florida

Phone: 352-294-5691

Email: allisonallegra3@ufl.edu

Results disclosure agreements

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