Trial Outcomes & Findings for Calcium Aluminosilicate Anti-Diarrheal in Treating and Preventing Diarrhea in Patients With Metastatic Colorectal Cancer Receiving Irinotecan (NCT NCT00748215)

NCT ID: NCT00748215

Last Updated: 2020-12-02

Results Overview

One hundred patients were randomized equally between CASAD and placebo arms in order to assess whether CASAD was efficacious in preventing grade 3/4 diarrhea within 6 weeks for each arm compared. Bayesian futility monitoring in the study with a recommendation to stop the trial for futility if it became clear that CASAD was not better than placebo.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 100 participants
• Primary outcome timeframe: First 6 weeks from baseline in initial intervention with CASAD or PLACEBO
• Results posted on: 2020-12-02

Participant Flow

Recruitment Period: February 04, 2009 to May 3, 2012. All recruitment done at the University of Texas (UT) MD Anderson Cancer Center.

Of the original 100 patients enrolled and randomized to the 6 week intervention period, 39 patients would go on to take open label CASAD; 22 patients from the CASAD arm and 17 patients from the placebo arm. These patients were added as a Milestone on the Participant Flow sheet. 8 patients received open label for <21 days; 31 patients received open label CASAD for >21 days.

Participant milestones

Measure	Arm I: Calcium Aluminosilicate Anti-Diarrheal (CASAD) Oral calcium aluminosilicate anti-diarrheal (CASAD) 4 times daily for 6 weeks in the absence of disease progression or unacceptable toxicity. Participants who develop grade 3 or 4 diarrhea may receive CASAD for an additional 6 weeks.	Arm II: Placebo Oral placebo 4 times daily for 6 weeks in the absence of disease progression or unacceptable toxicity. Participants who develop grade 3 or 4 diarrhea may then receive CASAD for 6 weeks.
Overall Study STARTED	50	50
Overall Study Open Label CASAD After Initial 6 Weeks Intervention	22	17
Overall Study COMPLETED	41	32
Overall Study NOT COMPLETED	9	18

Reasons for withdrawal

Measure	Arm I: Calcium Aluminosilicate Anti-Diarrheal (CASAD) Oral calcium aluminosilicate anti-diarrheal (CASAD) 4 times daily for 6 weeks in the absence of disease progression or unacceptable toxicity. Participants who develop grade 3 or 4 diarrhea may receive CASAD for an additional 6 weeks.	Arm II: Placebo Oral placebo 4 times daily for 6 weeks in the absence of disease progression or unacceptable toxicity. Participants who develop grade 3 or 4 diarrhea may then receive CASAD for 6 weeks.
Overall Study Withdrawal by Subject	7	7
Overall Study Treatment change	2	1
Overall Study Change in patient condition	0	3
Overall Study Non-compliant	0	2
Overall Study Adverse Event	0	5

Baseline Characteristics

Calcium Aluminosilicate Anti-Diarrheal in Treating and Preventing Diarrhea in Patients With Metastatic Colorectal Cancer Receiving Irinotecan

Baseline characteristics by cohort

Measure	Arm I: Calcium Aluminosilicate Anti-Diarrheal (CASAD) n=50 Participants Oral calcium aluminosilicate anti-diarrheal (CASAD) 4 times daily for 6 weeks in the absence of disease progression or unacceptable toxicity. Participants who develop grade 3 or 4 diarrhea may receive CASAD for an additional 6 weeks.	Arm II: Placebo n=50 Participants Oral placebo 4 times daily for 6 weeks in the absence of disease progression or unacceptable toxicity. Participants who develop grade 3 or 4 diarrhea may then receive CASAD for 6 weeks.	Total n=100 Participants Total of all reporting groups
Age, Continuous	57 Years n=5 Participants	56 Years n=7 Participants	56.5 Years n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	25 Participants n=7 Participants	46 Participants n=5 Participants
Sex: Female, Male Male	29 Participants n=5 Participants	25 Participants n=7 Participants	54 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	45 Participants n=5 Participants	44 Participants n=7 Participants	89 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants	9 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) White	42 Participants n=5 Participants	41 Participants n=7 Participants	83 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	50 participants n=5 Participants	50 participants n=7 Participants	100 participants n=5 Participants
Baseline Bowel Assessment (BBA) < 1 Per Day	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Baseline Bowel Assessment (BBA) < 1 -3 Per Day	7 Participants n=5 Participants	3 Participants n=7 Participants	10 Participants n=5 Participants
Baseline Bowel Assessment (BBA) < >3 Per Day	27 Participants n=5 Participants	34 Participants n=7 Participants	61 Participants n=5 Participants
Baseline Bowel Assessment (BBA) Other	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Baseline Ostomy Bowel Assessment (BOBA) 2-3 times	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Baseline Ostomy Bowel Assessment (BOBA) 4-6 times	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Baseline Ostomy Bowel Assessment (BOBA) >6 times	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Baseline Ostomy Bowel Assessment (BOBA) Other	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Baseline Bowel Assessment (BBA) No	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Baseline Bowel Assessment (BBA) Yes, some	24 Participants n=5 Participants	32 Participants n=7 Participants	56 Participants n=5 Participants
Baseline Bowel Assessment (BBA) Yes, significant	11 Participants n=5 Participants	8 Participants n=7 Participants	19 Participants n=5 Participants
Baseline Bowel Assessment (BBA) Not answered	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Baseline Bowel Assessment (BBA) Hard difficult to pass	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Baseline Bowel Assessment (BBA) Well-formed, easy to pass	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Baseline Bowel Assessment (BBA) Loose	25 Participants n=5 Participants	29 Participants n=7 Participants	54 Participants n=5 Participants
Baseline Bowel Assessment (BBA) Very loose and watery	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Baseline Bowel Assessment (BBA) 1/4 Full	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Baseline Bowel Assessment (BBA) 1/3 Full (recommended)	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Baseline Bowel Assessment (BBA) 1/2 Full	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Baseline Ostomy Bowel Assessment (BOBA) Does not measure output	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Baseline Ostomy Bowel Assessment (BOBA) <200 ml/day	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Baseline Ostomy Bowel Assessment (BOBA) 200-600 ml/day (typical)	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Baseline Ostomy Bowel Assessment (BOBA) 600-1000 ml/day	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Baseline Ostomy Bowel Assessment (BOBA) >1000 ml/day	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Baseline Ostomy Bowel Assessment (BOBA) No	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Baseline Ostomy Bowel Assessment (BOBA) Yes, some	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Baseline Ostomy Bowel Assessment (BOBA) Yes, significant	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Baseline Ostomy Bowel Assessment (BOBA) Well-formed, easy to pass	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Baseline Ostomy Bowel Assessment (BOBA) Semi-formed (peanut butter consistency)	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Baseline Ostomy Bowel Assessment (BOBA) Loose (pudding, cake batter consistency)	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Baseline Ostomy Bowel Assessment (BOBA) Very loose and watery	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: First 6 weeks from baseline in initial intervention with CASAD or PLACEBO

Population: Patients who experienced any diarrhea during the intervention period and patients who experienced Grade 3/4 diarrhea during the intervention period.

One hundred patients were randomized equally between CASAD and placebo arms in order to assess whether CASAD was efficacious in preventing grade 3/4 diarrhea within 6 weeks for each arm compared. Bayesian futility monitoring in the study with a recommendation to stop the trial for futility if it became clear that CASAD was not better than placebo.

Outcome measures

Measure	Arm I: Calcium Aluminosilicate Anti-Diarrheal (CASAD) n=49 Participants Oral calcium aluminosilicate anti-diarrheal (CASAD) 4 times daily for 6 weeks in the absence of disease progression or unacceptable toxicity. Participants who develop grade 3 or 4 diarrhea may receive CASAD for an additional 6 weeks.	Arm II: Placebo n=46 Participants Oral placebo 4 times daily for 6 weeks in the absence of disease progression or unacceptable toxicity. Participants who develop grade 3 or 4 diarrhea may then receive CASAD for 6 weeks.
Number of Participants With Grade 3/4 Diarrhea Any diarrhea in first 6 weeks	27 Participants	26 Participants
Number of Participants With Grade 3/4 Diarrhea Grade 3/4 diarrhea in first 6 weeks	7 Participants	3 Participants

Adverse Events

Arm I: Calcium Aluminosilicate Anti-Diarrheal (CASAD)

Serious events: 4 serious events

Other events: 50 other events

Deaths: 1 deaths

Arm II: Placebo

Serious events: 9 serious events

Other events: 50 other events

Deaths: 0 deaths

Serious adverse events

Measure	Arm I: Calcium Aluminosilicate Anti-Diarrheal (CASAD) n=50 participants at risk Oral calcium aluminosilicate anti-diarrheal (CASAD) 4 times daily for 6 weeks in the absence of disease progression or unacceptable toxicity. Participants who develop grade 3 or 4 diarrhea may receive CASAD for an additional 6 weeks.	Arm II: Placebo n=50 participants at risk Oral placebo 4 times daily for 6 weeks in the absence of disease progression or unacceptable toxicity. Participants who develop grade 3 or 4 diarrhea may then receive CASAD for 6 weeks.
Blood and lymphatic system disorders Neutropenia	4.0% 2/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	0.00% 0/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Gastrointestinal disorders Obstruction	0.00% 0/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	4.0% 2/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Infections and infestations Febrile Neutropenia	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
General disorders Abdominal Pain	0.00% 0/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	4.0% 2/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Renal and urinary disorders Renal Failure	0.00% 0/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Musculoskeletal and connective tissue disorders Fracture - skull	0.00% 0/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Nervous system disorders Hemorrhage - intracranial	0.00% 0/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Renal and urinary disorders Creatinine - elevated	0.00% 0/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Gastrointestinal disorders Abdominal Distention	0.00% 0/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Gastrointestinal disorders Dehydration	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	0.00% 0/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Gastrointestinal disorders Diarrhea	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	0.00% 0/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)

Other adverse events

Measure	Arm I: Calcium Aluminosilicate Anti-Diarrheal (CASAD) n=50 participants at risk Oral calcium aluminosilicate anti-diarrheal (CASAD) 4 times daily for 6 weeks in the absence of disease progression or unacceptable toxicity. Participants who develop grade 3 or 4 diarrhea may receive CASAD for an additional 6 weeks.	Arm II: Placebo n=50 participants at risk Oral placebo 4 times daily for 6 weeks in the absence of disease progression or unacceptable toxicity. Participants who develop grade 3 or 4 diarrhea may then receive CASAD for 6 weeks.
Nervous system disorders Tremor	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	0.00% 0/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Gastrointestinal disorders Vomiting	26.0% 13/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	32.0% 16/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Immune system disorders Watering eyes	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	0.00% 0/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Investigations Weight gain	0.00% 0/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Reproductive system and breast disorders Urinary incontinence	0.00% 0/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Reproductive system and breast disorders Urinary retention	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	0.00% 0/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Reproductive system and breast disorders Urinary tract infection	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Cardiac disorders Vascular disorders	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	6.0% 3/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Reproductive system and breast disorders Vaginal dryness	0.00% 0/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Respiratory, thoracic and mediastinal disorders Voice changes	0.00% 0/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	4.0% 2/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Gastrointestinal disorders Abdominal distention	4.0% 2/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	4.0% 2/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
General disorders Abdominal pain	14.0% 7/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	18.0% 9/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Blood and lymphatic system disorders Act prtl thromboplast t prolonged	0.00% 0/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	4.0% 2/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Respiratory, thoracic and mediastinal disorders Adult respiratory distress syndrome	0.00% 0/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Nervous system disorders Agitation	4.0% 2/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	0.00% 0/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Metabolism and nutrition disorders Alanine Aminotransferase increase	6.0% 3/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	6.0% 3/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Metabolism and nutrition disorders Alkaline phosphatase increase	10.0% 5/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	12.0% 6/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Immune system disorders Allergic reaction	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	0.00% 0/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Immune system disorders Allergic rhinitis	6.0% 3/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Skin and subcutaneous tissue disorders Alopecia	22.0% 11/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	14.0% 7/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
General disorders Anal pain	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	0.00% 0/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Metabolism and nutrition disorders Anemia	20.0% 10/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	24.0% 12/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Gastrointestinal disorders Anorexia	28.0% 14/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	12.0% 6/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Nervous system disorders Anxiety	8.0% 4/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	12.0% 6/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Immune system disorders Arthralgia	0.00% 0/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	6.0% 3/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Musculoskeletal and connective tissue disorders Arthritis	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	0.00% 0/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Metabolism and nutrition disorders Aspartate aminotransferase increase	4.0% 2/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	4.0% 2/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Cardiac disorders Atrial fibrillation	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	0.00% 0/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
General disorders Back pain	8.0% 4/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Gastrointestinal disorders Bloating	4.0% 2/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Metabolism and nutrition disorders Blood bilirubin increase	4.0% 2/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	6.0% 3/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
General disorders Bone pain	0.00% 0/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Skin and subcutaneous tissue disorders Bruising	0.00% 0/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
General disorders Buttock pain	0.00% 0/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Nervous system disorders Cognitive disturbance	0.00% 0/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Nervous system disorders Confusion	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Gastrointestinal disorders Constipation	46.0% 23/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	38.0% 19/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Respiratory, thoracic and mediastinal disorders Cough	4.0% 2/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	4.0% 2/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Metabolism and nutrition disorders Creatinine increase	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	10.0% 5/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Gastrointestinal disorders Dehydration	14.0% 7/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	6.0% 3/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Nervous system disorders Depr level of consciousness	0.00% 0/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Nervous system disorders Depression	14.0% 7/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	10.0% 5/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Gastrointestinal disorders Diarrhea	62.0% 31/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	0.00% 0/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Nervous system disorders Dizziness	12.0% 6/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	6.0% 3/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Gastrointestinal disorders Dry mouth	14.0% 7/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	10.0% 5/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Skin and subcutaneous tissue disorders Dry skin	4.0% 2/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Gastrointestinal disorders Dysgeusia	4.0% 2/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	4.0% 2/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Gastrointestinal disorders Dyspepsia	10.0% 5/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	6.0% 3/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Gastrointestinal disorders Dysphagia	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	0.00% 0/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Respiratory, thoracic and mediastinal disorders Dyspnea	6.0% 3/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	4.0% 2/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Ear and labyrinth disorders Ear and labyrinth disorders	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	0.00% 0/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Cardiac disorders Edema limbs	6.0% 3/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	8.0% 4/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Endocrine disorders Endocrine disorders	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	0.00% 0/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Respiratory, thoracic and mediastinal disorders Epistaxis	6.0% 3/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	8.0% 4/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Eye disorders Eye disorders	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	4.0% 2/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Eye disorders Eyelid function disorder	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	0.00% 0/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
General disorders Fatigue	58.0% 29/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	42.0% 21/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Blood and lymphatic system disorders Febrile Neutropenia	0.00% 0/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
General disorders Fever	4.0% 2/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Gastrointestinal disorders Flatulence	10.0% 5/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	8.0% 4/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Immune system disorders Flushing	4.0% 2/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Musculoskeletal and connective tissue disorders Fracture	0.00% 0/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Musculoskeletal and connective tissue disorders Gastroesophageal reflux	0.00% 0/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Gastrointestinal disorders Gastrointestinal disorders	18.0% 9/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	14.0% 7/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Gastrointestinal disorders Gastrointestinal pain	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
General disorders Gen disorders & admin site condition	10.0% 5/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	4.0% 2/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Musculoskeletal and connective tissue disorders Generalized muscle weakness	4.0% 2/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	4.0% 2/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Reproductive system and breast disorders Genital edema	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	0.00% 0/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Endocrine disorders Glucose intolerance	0.00% 0/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Nervous system disorders Headache	14.0% 7/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	0.00% 0/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Reproductive system and breast disorders Hematuria	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Metabolism and nutrition disorders Hemoglobin increased	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	0.00% 0/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Gastrointestinal disorders Hemorrhoids	8.0% 4/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Gastrointestinal disorders Hiccups	0.00% 0/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Respiratory, thoracic and mediastinal disorders Hoarseness	0.00% 0/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Reproductive system and breast disorders Hot flashes	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	0.00% 0/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Metabolism and nutrition disorders Hyperglycemia	18.0% 9/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	16.0% 8/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Skin and subcutaneous tissue disorders Hyperhidrosis	4.0% 2/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Metabolism and nutrition disorders Hyperkalemia	8.0% 4/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	0.00% 0/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Nervous system disorders Hypersomnia	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	0.00% 0/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Metabolism and nutrition disorders Hypoalbuminemia	8.0% 4/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	0.00% 0/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Metabolism and nutrition disorders Hypocalcemia	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	8.0% 4/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Metabolism and nutrition disorders Hypoglycemia	0.00% 0/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	6.0% 3/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Metabolism and nutrition disorders Hypokalemia	6.0% 3/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	14.0% 7/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Metabolism and nutrition disorders Hypomagnesmia	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	10.0% 5/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Metabolism and nutrition disorders Hyponatremia	10.0% 5/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	12.0% 6/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Metabolism and nutrition disorders Hypophosphatemia	0.00% 0/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Endocrine disorders Hypothryoidism	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	0.00% 0/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Respiratory, thoracic and mediastinal disorders Hypoxia	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Metabolism and nutrition disorders INR increase	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	0.00% 0/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Immune system disorders Immune system disorders	4.0% 2/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	0.00% 0/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Infections and infestations Infections and infestations	8.0% 4/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	6.0% 3/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Nervous system disorders Insomnia	8.0% 4/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	10.0% 5/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Gastrointestinal disorders Intestinal stoma obstruction	0.00% 0/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Investigations Investigations	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	8.0% 4/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Musculoskeletal and connective tissue disorders Joint range of motion decreased	0.00% 0/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Metabolism and nutrition disorders Lymphocyte count decrease	10.0% 5/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	4.0% 2/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
General disorders Malaise	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	0.00% 0/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Nervous system disorders Memory impairment	4.0% 2/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Metabolism and nutrition disorders Metabolism & nurtition disorders	6.0% 3/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Gastrointestinal disorders Mucosal infection	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	0.00% 0/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Gastrointestinal disorders Mucositis oral	16.0% 8/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	8.0% 4/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	0.00% 0/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder	4.0% 2/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Musculoskeletal and connective tissue disorders Myalgia	8.0% 4/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	0.00% 0/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Skin and subcutaneous tissue disorders Nail loss	0.00% 0/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Skin and subcutaneous tissue disorders Nail ridging	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	0.00% 0/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Gastrointestinal disorders Nausea	46.0% 23/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	50.0% 25/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
General disorders Neck pain	4.0% 2/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	0.00% 0/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Nervous system disorders Nervous system disorders	12.0% 6/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	6.0% 3/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Metabolism and nutrition disorders Neutrophil count decrease	12.0% 6/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	16.0% 8/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Gastrointestinal disorders Obesity	0.00% 0/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Gastrointestinal disorders Obstruction gastric	0.00% 0/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	4.0% 2/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Gastrointestinal disorders Oral dysethesia	0.00% 0/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
General disorders Oral pain	0.00% 0/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	4.0% 2/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
General disorders Pain	22.0% 11/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	18.0% 9/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
General disorders Pain in extremity	4.0% 2/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	6.0% 3/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthias	0.00% 0/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Cardiac disorders Palpitations	0.00% 0/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Nervous system disorders Paresthesia	6.0% 3/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Infections and infestations Paronychia	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	0.00% 0/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Nervous system disorders Peripheral motor neuropathy	4.0% 2/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	0.00% 0/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Nervous system disorders Peripheral sensory neruopathy	22.0% 11/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	8.0% 4/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Metabolism and nutrition disorders Platelet count descreased	6.0% 3/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	10.0% 5/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Respiratory, thoracic and mediastinal disorders Pleuritic pain	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	0.00% 0/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Skin and subcutaneous tissue disorders Pruritus	8.0% 4/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	4.0% 2/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Skin and subcutaneous tissue disorders Purpura	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Skin and subcutaneous tissue disorders Rash acneiform	12.0% 6/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	12.0% 6/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Skin and subcutaneous tissue disorders Rash maculo-papular	4.0% 2/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	8.0% 4/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Gastrointestinal disorders Rectal hemorrhage	4.0% 2/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	4.0% 2/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Reproductive system and breast disorders Renal and urinary disorders	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	4.0% 2/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic & mediastinal disorders	6.0% 3/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Reproductive system and breast disorders Reproductive system & breast disorders	0.00% 0/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Gastrointestinal disorders Salivary duct inflammation	0.00% 0/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Cardiac disorders Sinus bradycardia	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	0.00% 0/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders	16.0% 8/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	4.0% 2/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Skin and subcutaneous tissue disorders Skin hyperpigmentation	0.00% 0/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Nervous system disorders Somnolence	4.0% 2/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Respiratory, thoracic and mediastinal disorders Sore throat	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
General disorders Stomach pain	4.0% 2/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	0.00% 0/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Blood and lymphatic system disorders Thromboembolic event	0.00% 0/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Ear and labyrinth disorders Tinnitus	0.00% 0/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Investigations Weight loss	4.0% 2/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	0.00% 0/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Respiratory, thoracic and mediastinal disorders Wheezing	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	0.00% 0/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Skin and subcutaneous tissue disorders Wound complication	0.00% 0/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	2.0% 1/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)
Metabolism and nutrition disorders White blood cell decreased	6.0% 3/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)	12.0% 6/50 • Baseline at enrollment through 30 days following being taken off treatment for each participant, an average of 10 weeks An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE)

Additional Information

Bryan Kee, MD/Assistant Professor, GI Medical Oncology

University of Texas (UT) MD Anderson Cancer Center

Phone: 713-792-2828

Email: bkkee@mdanderson.org

Results disclosure agreements

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