Trial Outcomes & Findings for Celecoxib With or Without Eflornithine in Preventing Colorectal Cancer in Patients With Familial Adenomatous Polyposis (NCT NCT00033371)

NCT ID: NCT00033371

Last Updated: 2020-09-29

Results Overview

Differences between average treatment effects of two study arms tested using two-sided type I error rate of 5% in two-sample t-test. If model assumptions not met by data or transformations of data, appropriate nonparametric tests (e.g. Wilcoxon rank sums test) were used to compare treatment arms - Percent change of polyp counts from baseline to 6 months, ie \[(6 months - baseline) x 100\]/baseline (%). For each participant, first were matched polyps between baseline \& 6 months by region and landmark and summed over all matched regions on number of polyps \>2 mm to calculate total number of polyps \>2 mm at baseline \& 6 months, respectively. For participants refusing exit colonoscopy, 0% change entered as primary endpoint. Defined ITT All: All patients; if 6-month polyp counts missing = 0% change; ITT Measurable: All participants with baseline \& 6 month polyp counts; ITT Evaluable: ITT Measurable participants who also took 80% of treatment, both overall as well as during final 60 days.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 205 participants
• Primary outcome timeframe: Baseline up to 6 months
• Results posted on: 2020-09-29

Participant Flow

Recruitment Period: December 13, 2001 to October 21, 2008. All recruitment done in medical clinics, with the trial conducted at the University of Texas MD Anderson Cancer, the Cleveland Clinic in Cleveland and St. Mark's Hospital in Harrow, UK.

Of the 205 participants with familial adenomatous polyposis (FAP) recruited, 112 were randomized. The study was closed due to slow recruitment with enrollment target almost met.

Participant milestones

Measure	Arm I: Celecoxib and Placebo Celecoxib 400 mg orally twice daily (PO BID) and Placebo once a day. Treatment continues for 6 months (up to 200 days).	Arm II: Celecoxib and Eflornithine Celecoxib 400 mg PO BID and Eflornithine PO daily 0.5 g/m\^2/day rounded down to the nearest 250 mg dose (body surface area (BSA) of \< 1.4 = 500 mg/day; BSA of 1.5 - 2.0 = 750 mg/day; BSA of 2.1 - 2.5 = 1000 mg/day; BSA of \> 2.6 = 1,250 mg/day). Treatment continues for 6 months (up to 200 days).
Overall Study STARTED	55	57
Overall Study COMPLETED	49	47
Overall Study NOT COMPLETED	6	10

Reasons for withdrawal

Measure	Arm I: Celecoxib and Placebo Celecoxib 400 mg orally twice daily (PO BID) and Placebo once a day. Treatment continues for 6 months (up to 200 days).	Arm II: Celecoxib and Eflornithine Celecoxib 400 mg PO BID and Eflornithine PO daily 0.5 g/m\^2/day rounded down to the nearest 250 mg dose (body surface area (BSA) of \< 1.4 = 500 mg/day; BSA of 1.5 - 2.0 = 750 mg/day; BSA of 2.1 - 2.5 = 1000 mg/day; BSA of \> 2.6 = 1,250 mg/day). Treatment continues for 6 months (up to 200 days).
Overall Study Adverse Event	1	5
Overall Study Lost to Follow-up	2	1
Overall Study Withdrawal by Subject	3	3
Overall Study Disease Progression	0	1

Baseline Characteristics

Celecoxib With or Without Eflornithine in Preventing Colorectal Cancer in Patients With Familial Adenomatous Polyposis

Baseline characteristics by cohort

Measure	Arm I: Celecoxib and Placebo n=55 Participants Celecoxib 400 mg orally twice daily (PO BID) and Placebo once a day. Treatment continues for 6 months (up to 200 days).	Arm II: Celecoxib and Eflornithine n=57 Participants Celecoxib 400 mg PO BID and Eflornithine PO daily 0.5 g/m\^2/day rounded down to the nearest 250 mg dose (body surface area (BSA) of \< 1.4 = 500 mg/day; BSA of 1.5 - 2.0 = 750 mg/day; BSA of 2.1 - 2.5 = 1000 mg/day; BSA of \> 2.6 = 1,250 mg/day). Treatment continues for 6 months (up to 200 days).	Total n=112 Participants Total of all reporting groups
Age, Continuous	38 years n=5 Participants	38 years n=7 Participants	38 years n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	27 Participants n=7 Participants	52 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=5 Participants	4 Participants n=7 Participants	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	46 Participants n=5 Participants	50 Participants n=7 Participants	96 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	3 Participants n=7 Participants	5 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	0 Participants n=5 Participants	1 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	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	53 Participants n=5 Participants	53 Participants n=7 Participants	106 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	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	42 participants n=5 Participants	43 participants n=7 Participants	85 participants n=5 Participants
Region of Enrollment United Kingdom	13 participants n=5 Participants	14 participants n=7 Participants	27 participants n=5 Participants
Basis of FAP Diagnosis >100 Polyps	21 participants n=5 Participants	23 participants n=7 Participants	44 participants n=5 Participants
Basis of FAP Diagnosis >10 Polyps and age <40	28 participants n=5 Participants	23 participants n=7 Participants	51 participants n=5 Participants
Basis of FAP Diagnosis >25 Polyps and age >40	6 participants n=5 Participants	11 participants n=7 Participants	17 participants n=5 Participants
Colon versus Rectum Colon	19 participants n=5 Participants	27 participants n=7 Participants	46 participants n=5 Participants
Colon versus Rectum Rectum Only	36 participants n=5 Participants	30 participants n=7 Participants	66 participants n=5 Participants
Number of Landmark Polyps at Baseline Screen 0-1	3 participants n=5 Participants	5 participants n=7 Participants	8 participants n=5 Participants
Number of Landmark Polyps at Baseline Screen 2-4	7 participants n=5 Participants	12 participants n=7 Participants	19 participants n=5 Participants
Number of Landmark Polyps at Baseline Screen 5-9	19 participants n=5 Participants	21 participants n=7 Participants	40 participants n=5 Participants
Number of Landmark Polyps at Baseline Screen 10 or more	22 participants n=5 Participants	19 participants n=7 Participants	41 participants n=5 Participants
Number of Landmark Polyps at Baseline Screen No Baseline Screen	4 participants n=5 Participants	0 participants n=7 Participants	4 participants n=5 Participants
Number of Landmark Polyps at least 2 mm at Baseline Screen 0-1	13 participants n=5 Participants	20 participants n=7 Participants	33 participants n=5 Participants
Number of Landmark Polyps at least 2 mm at Baseline Screen 2-4	12 participants n=5 Participants	23 participants n=7 Participants	35 participants n=5 Participants
Number of Landmark Polyps at least 2 mm at Baseline Screen 5-9	22 participants n=5 Participants	8 participants n=7 Participants	30 participants n=5 Participants
Number of Landmark Polyps at least 2 mm at Baseline Screen 10 or more	4 participants n=5 Participants	6 participants n=7 Participants	10 participants n=5 Participants
Number of Landmark Polyps at least 2 mm at Baseline Screen No Baseline Screen	4 participants n=5 Participants	0 participants n=7 Participants	4 participants n=5 Participants
Number Landmark Polyps at least 2 mm at Baseline Screen for Evaluable polyps, Evaluable Participants 0-1	9 participants n=5 Participants	13 participants n=7 Participants	22 participants n=5 Participants
Number Landmark Polyps at least 2 mm at Baseline Screen for Evaluable polyps, Evaluable Participants 2-4	11 participants n=5 Participants	13 participants n=7 Participants	24 participants n=5 Participants
Number Landmark Polyps at least 2 mm at Baseline Screen for Evaluable polyps, Evaluable Participants 5-9	13 participants n=5 Participants	5 participants n=7 Participants	18 participants n=5 Participants
Number Landmark Polyps at least 2 mm at Baseline Screen for Evaluable polyps, Evaluable Participants 10 or more	0 participants n=5 Participants	4 participants n=7 Participants	4 participants n=5 Participants
Number Landmark Polyps at least 2 mm at Baseline Screen for Evaluable polyps, Evaluable Participants No Baseline Screen	4 participants n=5 Participants	0 participants n=7 Participants	4 participants n=5 Participants
Number Landmark Polyps at least 2 mm at Baseline Screen for Evaluable polyps, Evaluable Participants Not Evaulable Participant	18 participants n=5 Participants	22 participants n=7 Participants	40 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline up to 6 months

Population: 112 patients were randomized to the study. Analysis was by intent to treat (ITT) with a total of 89 ITT participants measurable by having complete polyp information.

Differences between average treatment effects of two study arms tested using two-sided type I error rate of 5% in two-sample t-test. If model assumptions not met by data or transformations of data, appropriate nonparametric tests (e.g. Wilcoxon rank sums test) were used to compare treatment arms - Percent change of polyp counts from baseline to 6 months, ie [(6 months - baseline) x 100]/baseline (%). For each participant, first were matched polyps between baseline & 6 months by region and landmark and summed over all matched regions on number of polyps >2 mm to calculate total number of polyps >2 mm at baseline & 6 months, respectively. For participants refusing exit colonoscopy, 0% change entered as primary endpoint. Defined ITT All: All patients; if 6-month polyp counts missing = 0% change; ITT Measurable: All participants with baseline & 6 month polyp counts; ITT Evaluable: ITT Measurable participants who also took 80% of treatment, both overall as well as during final 60 days.

Outcome measures

Measure	Arm I: Celecoxib and Placebo n=55 Participants Celecoxib 400 mg orally twice daily (PO BID) and Placebo once a day. Treatment continues for 6 months (up to 200 days).	Arm II: Celecoxib and Eflornithine n=57 Participants Celecoxib 400 mg PO BID and Eflornithine PO daily 0.5 g/m\^2/day rounded down to the nearest 250 mg dose (body surface area (BSA) of \< 1.4 = 500 mg/day; BSA of 1.5 - 2.0 = 750 mg/day; BSA of 2.1 - 2.5 = 1000 mg/day; BSA of \> 2.6 = 1,250 mg/day). Treatment continues for 6 months (up to 200 days).
Percent Change in the Number of Polyps Greater Than or Equal to 2mm in Diameter in Focal Area(s) of the Colorectum ITT All	-1 percentage change in polyp count Standard Error 0.11	-11 percentage change in polyp count Standard Error 0.08
Percent Change in the Number of Polyps Greater Than or Equal to 2mm in Diameter in Focal Area(s) of the Colorectum ITT Measurable	-1 percentage change in polyp count Standard Error 0.14	-13 percentage change in polyp count Standard Error 0.10
Percent Change in the Number of Polyps Greater Than or Equal to 2mm in Diameter in Focal Area(s) of the Colorectum ITT Evaluable	10 percentage change in polyp count Standard Error 0.18	-8 percentage change in polyp count Standard Error 0.12

PRIMARY outcome

Timeframe: 6 months

Population: Total of 57 participants in Arm II, 1 participant is missing AE data

To determine the relative tolerability and safety of celecoxib + DFMO in FAP study participants. Includes only adverse events that occurred in at least 5% of the patients or a patient exhibited at least 1 grade 3 toxicity.

Outcome measures

Measure	Arm I: Celecoxib and Placebo n=55 Participants Celecoxib 400 mg orally twice daily (PO BID) and Placebo once a day. Treatment continues for 6 months (up to 200 days).	Arm II: Celecoxib and Eflornithine n=56 Participants Celecoxib 400 mg PO BID and Eflornithine PO daily 0.5 g/m\^2/day rounded down to the nearest 250 mg dose (body surface area (BSA) of \< 1.4 = 500 mg/day; BSA of 1.5 - 2.0 = 750 mg/day; BSA of 2.1 - 2.5 = 1000 mg/day; BSA of \> 2.6 = 1,250 mg/day). Treatment continues for 6 months (up to 200 days).
Number of Participants With Adverse Events Occurring at a Frequency of 5% or Grade 3 and Higher High-frequency hearing loss	4 Participants	7 Participants
Number of Participants With Adverse Events Occurring at a Frequency of 5% or Grade 3 and Higher Fatigue	11 Participants	3 Participants
Number of Participants With Adverse Events Occurring at a Frequency of 5% or Grade 3 and Higher Diarrhoea	6 Participants	4 Participants
Number of Participants With Adverse Events Occurring at a Frequency of 5% or Grade 3 and Higher Heartburn/dyspepsia	4 Participants	2 Participants
Number of Participants With Adverse Events Occurring at a Frequency of 5% or Grade 3 and Higher Mucositis/stomatitis	11 Participants	15 Participants
Number of Participants With Adverse Events Occurring at a Frequency of 5% or Grade 3 and Higher Nausea/vomiting	6 Participants	7 Participants
Number of Participants With Adverse Events Occurring at a Frequency of 5% or Grade 3 and Higher Gout	0 Participants	1 Participants
Number of Participants With Adverse Events Occurring at a Frequency of 5% or Grade 3 and Higher Headache	5 Participants	1 Participants

SECONDARY outcome

Timeframe: 6 months

Population: A total of 89 participants had complete polyp information at baseline and 6 months.

Percentage Change in Global Colorectal Polyps burden

Outcome measures

Measure	Arm I: Celecoxib and Placebo n=44 Participants Celecoxib 400 mg orally twice daily (PO BID) and Placebo once a day. Treatment continues for 6 months (up to 200 days).	Arm II: Celecoxib and Eflornithine n=45 Participants Celecoxib 400 mg PO BID and Eflornithine PO daily 0.5 g/m\^2/day rounded down to the nearest 250 mg dose (body surface area (BSA) of \< 1.4 = 500 mg/day; BSA of 1.5 - 2.0 = 750 mg/day; BSA of 2.1 - 2.5 = 1000 mg/day; BSA of \> 2.6 = 1,250 mg/day). Treatment continues for 6 months (up to 200 days).
Percentage Change in Global Colorectal Polyps Burden	-27 percentage change of total Polyps burden Standard Error 6	-40 percentage change of total Polyps burden Standard Error 6

SECONDARY outcome

Timeframe: 6 months

Population: The data was inevaluable to determine the percent change in the area of plaque-like duodenal polyps

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Population: The data was inevaluable to determine the global duodenal polyp burden

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline up to 2 months after completion of study treatment

Population: No data collected to determine the percentage change in polyp size in focal area(s) of the colorectum.

Outcome measures

Outcome data not reported

Adverse Events

Arm I: Celecoxib and Placebo

Serious events: 0 serious events

Other events: 53 other events

Deaths: 0 deaths

Arm II: Celecoxib and Eflornithine

Serious events: 3 serious events

Other events: 48 other events

Deaths: 0 deaths

Serious adverse events

Measure	Arm I: Celecoxib and Placebo n=55 participants at risk Celecoxib 400 mg orally twice daily (PO BID) and Placebo once a day. Treatment continues for 6 months (up to 200 days).	Arm II: Celecoxib and Eflornithine n=57 participants at risk Celecoxib 400 mg PO BID and Eflornithine PO daily 0.5 g/m\^2/day rounded down to the nearest 250 mg dose (body surface area (BSA) of \< 1.4 = 500 mg/day; BSA of 1.5 - 2.0 = 750 mg/day; BSA of 2.1 - 2.5 = 1000 mg/day; BSA of \> 2.6 = 1,250 mg/day). Treatment continues for 6 months (up to 200 days).
Gastrointestinal disorders Obstruction: Small Bowel NOS	0.00% 0/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	1.8% 1/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Gastrointestinal disorders Perforation GI - Colon	0.00% 0/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	1.8% 1/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Hepatobiliary disorders Pancreatitis	0.00% 0/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	1.8% 1/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.

Other adverse events

Measure	Arm I: Celecoxib and Placebo n=55 participants at risk Celecoxib 400 mg orally twice daily (PO BID) and Placebo once a day. Treatment continues for 6 months (up to 200 days).	Arm II: Celecoxib and Eflornithine n=57 participants at risk Celecoxib 400 mg PO BID and Eflornithine PO daily 0.5 g/m\^2/day rounded down to the nearest 250 mg dose (body surface area (BSA) of \< 1.4 = 500 mg/day; BSA of 1.5 - 2.0 = 750 mg/day; BSA of 2.1 - 2.5 = 1000 mg/day; BSA of \> 2.6 = 1,250 mg/day). Treatment continues for 6 months (up to 200 days).
Immune system disorders Allergies, seasonal	0.00% 0/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	3.5% 2/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Immune system disorders Allergic rhinitis	5.5% 3/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	0.00% 0/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Immune system disorders Allergic reaction (food)	0.00% 0/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	1.8% 1/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Ear and labyrinth disorders High Frequency Hearing loss	9.1% 5/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	12.3% 7/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Ear and labyrinth disorders Otitis	14.5% 8/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	5.3% 3/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Ear and labyrinth disorders Tinnitus	9.1% 5/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	5.3% 3/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Ear and labyrinth disorders Hearing Impairment/Loss	12.7% 7/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	7.0% 4/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Blood and lymphatic system disorders Hemoglobin Change	0.00% 0/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	3.5% 2/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	1.8% 1/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Blood and lymphatic system disorders Low Platelet	0.00% 0/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	3.5% 2/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Cardiac disorders Cardiac ischemia (unstable angina)	1.8% 1/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	0.00% 0/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Cardiac disorders Chest tightness	1.8% 1/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	1.8% 1/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Cardiac disorders Hypertension	5.5% 3/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	1.8% 1/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Cardiac disorders Orthostatic Hypotension	1.8% 1/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	0.00% 0/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Cardiac disorders Palpitations	5.5% 3/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	3.5% 2/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
General disorders Fatigue	29.1% 16/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	21.1% 12/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
General disorders Fever	1.8% 1/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	3.5% 2/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
General disorders Insomnia	12.7% 7/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	7.0% 4/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
General disorders Night sweats	0.00% 0/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	1.8% 1/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
General disorders Weight gain	14.5% 8/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	10.5% 6/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
General disorders Weight loss	1.8% 1/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	3.5% 2/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Skin and subcutaneous tissue disorders Bruising	5.5% 3/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	5.3% 3/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Skin and subcutaneous tissue disorders Hair loss/alopecia	3.6% 2/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	0.00% 0/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Skin and subcutaneous tissue disorders Nail changes	0.00% 0/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	3.5% 2/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Skin and subcutaneous tissue disorders Nodules	1.8% 1/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	1.8% 1/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Skin and subcutaneous tissue disorders Pruritis/Itching	9.1% 5/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	7.0% 4/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Skin and subcutaneous tissue disorders Psoriasis	0.00% 0/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	1.8% 1/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Skin and subcutaneous tissue disorders Rash & Itching	10.9% 6/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	10.5% 6/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Skin and subcutaneous tissue disorders Other skin issues	0.00% 0/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	5.3% 3/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Endocrine disorders Hot flashes	3.6% 2/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	3.5% 2/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Gastrointestinal disorders Anorexia	1.8% 1/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	5.3% 3/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Gastrointestinal disorders Flatulence	7.3% 4/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	5.3% 3/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Gastrointestinal disorders Constipation	1.8% 1/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	3.5% 2/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Gastrointestinal disorders Dehydration	1.8% 1/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	0.00% 0/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Gastrointestinal disorders Diarrhea	30.9% 17/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	26.3% 15/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Gastrointestinal disorders Dry mouth	0.00% 0/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	1.8% 1/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Gastrointestinal disorders Dysphagia	1.8% 1/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	0.00% 0/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Gastrointestinal disorders Esophagitis	1.8% 1/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	1.8% 1/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Gastrointestinal disorders Heartburn/Dyspepsia	25.5% 14/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	19.3% 11/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Gastrointestinal disorders Mucositis/Stomatitis	27.3% 15/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	40.4% 23/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Gastrointestinal disorders Nausea/Vomiting	21.8% 12/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	28.1% 16/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Gastrointestinal disorders Stricture: Rectum	0.00% 0/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	1.8% 1/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Gastrointestinal disorders Taste alteration	0.00% 0/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	1.8% 1/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Gastrointestinal disorders Ulcers	1.8% 1/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	1.8% 1/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Blood and lymphatic system disorders Bloody stools	0.00% 0/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	1.8% 1/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Blood and lymphatic system disorders Hand & Wrist, Hemorrhage/Bleeding	0.00% 0/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	1.8% 1/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Blood and lymphatic system disorders Hematuria	1.8% 1/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	0.00% 0/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Blood and lymphatic system disorders Nose Bleed	3.6% 2/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	1.8% 1/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Blood and lymphatic system disorders Rectum, Hemorrhage/Bleeding	7.3% 4/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	8.8% 5/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Blood and lymphatic system disorders Vagina, Hemorrhage/Bleeding	0.00% 0/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	1.8% 1/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Infections and infestations Cold Sore (mouth)	1.8% 1/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	0.00% 0/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Infections and infestations Conjunctiva	0.00% 0/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	1.8% 1/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Infections and infestations Ear Infection	0.00% 0/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	1.8% 1/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Infections and infestations Head & Nasal Infection	1.8% 1/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	0.00% 0/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Infections and infestations Head (fungus) Infection	1.8% 1/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	0.00% 0/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Infections and infestations Lung Infection (pneumonia)	1.8% 1/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	0.00% 0/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Infections and infestations Infection, Nose (yellow nasal drainage)	1.8% 1/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	0.00% 0/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Infections and infestations Infection, Right leg (spider bite)	0.00% 0/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	1.8% 1/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Infections and infestations Sinus Infection	1.8% 1/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	0.00% 0/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Infections and infestations Infection, Stomach	3.6% 2/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	5.3% 3/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Infections and infestations Infection, Ungual	0.00% 0/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	3.5% 2/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Infections and infestations Infection, Upper airway NOS	5.5% 3/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	5.3% 3/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Blood and lymphatic system disorders Edema	7.3% 4/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	10.5% 6/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Metabolism and nutrition disorders ALT, SGPT Changes	1.8% 1/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	1.8% 1/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Metabolism and nutrition disorders AST, SGOT Changes	0.00% 0/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	1.8% 1/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Metabolism and nutrition disorders Alkaline phosphatase Changes	1.8% 1/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	0.00% 0/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Metabolism and nutrition disorders Creatinine Changes	0.00% 0/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	1.8% 1/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Metabolism and nutrition disorders Elevated LDL	0.00% 0/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	1.8% 1/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Metabolism and nutrition disorders Hyperbilirubinemia	3.6% 2/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	0.00% 0/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Metabolism and nutrition disorders Hypercholestremia & Hypertriglyceridemia	1.8% 1/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	1.8% 1/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Metabolism and nutrition disorders Hypocalcemia	0.00% 0/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	1.8% 1/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Metabolism and nutrition disorders Hypophosphatemia	0.00% 0/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	1.8% 1/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Metabolism and nutrition disorders Proteinuria	1.8% 1/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	1.8% 1/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Musculoskeletal and connective tissue disorders Ankle Sprain	0.00% 0/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	1.8% 1/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	1.8% 1/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Musculoskeletal and connective tissue disorders Muscle weakness, Extremity-lower	1.8% 1/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	3.5% 2/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Musculoskeletal and connective tissue disorders Fracture	0.00% 0/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	1.8% 1/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Musculoskeletal and connective tissue disorders Muscle/bone soreness from fall	0.00% 0/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	1.8% 1/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Musculoskeletal and connective tissue disorders Jaw tightness (left side)	1.8% 1/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	0.00% 0/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Musculoskeletal and connective tissue disorders Lower jaw tear	0.00% 0/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	1.8% 1/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Musculoskeletal and connective tissue disorders Puncture wound	0.00% 0/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	1.8% 1/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Musculoskeletal and connective tissue disorders Sutures in shoulder	1.8% 1/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	0.00% 0/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Nervous system disorders Cognitive Disturbance (ADD)	1.8% 1/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	0.00% 0/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Nervous system disorders Dizziness	12.7% 7/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	10.5% 6/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Nervous system disorders Memory Impairment	1.8% 1/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	1.8% 1/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Nervous system disorders Mood Alteration : Anxiety	3.6% 2/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	0.00% 0/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Nervous system disorders Mood alteration : Depression	1.8% 1/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	1.8% 1/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Nervous system disorders Numbness	5.5% 3/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	3.5% 2/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Nervous system disorders Numbness & Tingling	1.8% 1/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	0.00% 0/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Nervous system disorders Peripheral Neuropathy	1.8% 1/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	0.00% 0/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Nervous system disorders Somnolence	0.00% 0/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	1.8% 1/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Nervous system disorders Tingling	0.00% 0/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	1.8% 1/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Eye disorders Blurred Vision	5.5% 3/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	1.8% 1/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Eye disorders Bright lights	1.8% 1/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	0.00% 0/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Eye disorders Decreased vision (left eye)	1.8% 1/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	0.00% 0/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Eye disorders Decreased visual acuity	1.8% 1/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	0.00% 0/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Eye disorders Dry eye syndrome	0.00% 0/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	1.8% 1/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Eye disorders Eyelid scratch	1.8% 1/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	0.00% 0/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Eye disorders Near sighted	0.00% 0/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	1.8% 1/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Eye disorders Photophobia	0.00% 0/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	1.8% 1/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Eye disorders Tired eyes	1.8% 1/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	0.00% 0/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Eye disorders Unequal pupils	1.8% 1/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	0.00% 0/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Eye disorders Vision-floaters	0.00% 0/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	1.8% 1/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Eye disorders Watery eye	0.00% 0/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	1.8% 1/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Eye disorders Yellow discoloration (right ey	0.00% 0/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	1.8% 1/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
General disorders Pain, Abdomen	25.5% 14/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	15.8% 9/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
General disorders Pain, Wrist, Arm & Shoulder	3.6% 2/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	3.5% 2/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
General disorders Pain, Back	9.1% 5/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	7.0% 4/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
General disorders Pain, Breast (tenderness)	0.00% 0/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	1.8% 1/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
General disorders Pain, Breast bone	0.00% 0/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	1.8% 1/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
General disorders Pain, Cardiac/Heart	1.8% 1/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	1.8% 1/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
General disorders Pain, Chest/thorax NOS	1.8% 1/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	1.8% 1/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
General disorders Pain, Ear	3.6% 2/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	5.3% 3/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
General disorders Pain, Extremity-limb	3.6% 2/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	0.00% 0/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
General disorders Pain, Groin/Loin/Thigh	1.8% 1/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	3.5% 2/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
General disorders Headache	29.1% 16/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	24.6% 14/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
General disorders Pain, Joint/Musculoskeletal	10.9% 6/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	3.5% 2/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
General disorders Pain, Muscle	7.3% 4/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	3.5% 2/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
General disorders Pain, Neck	1.8% 1/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	0.00% 0/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
General disorders Pain, Oral-gums	1.8% 1/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	0.00% 0/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
General disorders Pain, Rectum	3.6% 2/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	1.8% 1/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
General disorders Pain, Throat/Pharynx	1.8% 1/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	10.5% 6/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
General disorders Pain, Vagina (cramping)	0.00% 0/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	1.8% 1/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Respiratory, thoracic and mediastinal disorders Bronchospasm, wheezing	7.3% 4/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	0.00% 0/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Respiratory, thoracic and mediastinal disorders Congestion	1.8% 1/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	1.8% 1/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Respiratory, thoracic and mediastinal disorders Cough	18.2% 10/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	10.5% 6/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Respiratory, thoracic and mediastinal disorders Dyspnea	14.5% 8/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	0.00% 0/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Respiratory, thoracic and mediastinal disorders Nasal cavity/paranasal sinus reaction	5.5% 3/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	5.3% 3/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Renal and urinary disorders Burning with urination	0.00% 0/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	1.8% 1/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Renal and urinary disorders Crystals in urine	1.8% 1/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	0.00% 0/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Renal and urinary disorders Kidney stone	1.8% 1/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	0.00% 0/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Renal and urinary disorders Urinary frequency	1.8% 1/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	0.00% 0/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Reproductive system and breast disorders Erectile dysfunction	1.8% 1/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	0.00% 0/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Reproductive system and breast disorders Irregular menses	1.8% 1/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	0.00% 0/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Reproductive system and breast disorders Irritation around genitals	1.8% 1/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	0.00% 0/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Injury, poisoning and procedural complications Intra-Operative Injury Extremity-Upper	1.8% 1/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	0.00% 0/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
Musculoskeletal and connective tissue disorders Gout	0.00% 0/55 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.	1.8% 1/57 • Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported. Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.

Additional Information

Patrick Lynch, MD/Professor, Gastroenterology/Hepatology

University of Texas (UT) MD Anderson Cancer Center

Phone: 713-794-5073

Email: plynch@mdanderson.org

Results disclosure agreements

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

Restriction type: LTE60