Trial Outcomes & Findings for Combination Chemotherapy With or Without Temsirolimus in Treating Patients With Intermediate Risk Rhabdomyosarcoma (NCT NCT02567435)

Last Updated: 2025-11-10

Results Overview

The Kaplan-Meier method will used to estimate 3-year EFS between the randomized treatment groups (Regimen A (VAC/VI) vs. Regimen B (VAC/VI/Temsirolimus)) using the log-rank test. EFS event is defined as the time from study entry until first occurrence of progression, relapse, second malignancy, or death.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE3

Target enrollment

325 participants

Primary outcome timeframe

Up to 3 years from study entry

Results posted on

2025-11-10

Participant Flow

This study was opened for enrollment on May 23, 2016, and was temporarily closed to accrual on September 23, 2016 for feasibility review. The study was re-opened for enrollment on January 2, 2018. The study was temporarily closed again on August 22, 2018 and re-opened on December 31, 2018 with the addition of maintenance therapy. The study is closed to accrual since 1/6/2022.

Among the 325 patients that enrolled, 4 patients were ineligible, 11 eligible patients were enrolled onto the feasibility phase (with 1 transferred to Regimen C), and 310 eligible patients were randomized and enrolled onto the efficacy phase (with 2 transferred to Regimen C). 13 randomized eligible patients were not analyzed (not evaluable due to FOXO1 diagnosis or amendment after study activated).

Participant milestones

Participant milestones
Measure	Regimen A (VAC/VI) Patients receive vincristine sulfate IV over 1 minute on day 1 of weeks 1-13, 16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40, dactinomycin IV over 1-5 or 10-15 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, cyclophosphamide IV over 60 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, irinotecan hydrochloride IV over 90 minutes on days 1-5 of weeks 4, 10, 16, 19, 25, 31, and 37. Patients also undergo primary site RT beginning at week 13 or metastatic site RT beginning at week 43 for up to 6.5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients then receive vinorelbine IV over 6-10 minutes on days 1, 8, and 15 and cyclophosphamide PO QD on days 1-28. Cycles repeats every 28 days for 24 weeks in the absence of disease progression or unacceptable toxicity.	Regimen B (VAC/VI/Temsirolimus) Patients receive vincristine sulfate IV over 1 minute on day 1 of weeks 1-13, 16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40, dactinomycin IV over 1-5 or 10-15 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, cyclophosphamide IV over 60 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, irinotecan hydrochloride IV over 90 minutes on days 1-5 of weeks 4, 10, 16, 19, 25, 31, and 37 and temsirolimus IV over 30-60 minutes on day 1 of weeks 1-12 and 21-42. Patients also undergo RT as in Regimen A. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients then receive vinorelbine IV over 6-10 minutes on days 1, 8, and 15 and cyclophosphamide PO QD on days 1-28. Cycles repeats every 28 days for 24 weeks in the absence of disease progression or unacceptable toxicity.	Regimen C (FOXO1 Fusion Negative, VAC/VA) Patients receive vincristine sulfate IV over 1 minute on day 1 of weeks 1-10 and 13-22, dactinomycin IV over 1-5 or 10-15 minutes on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, and 22, cyclophosphamide IV over 60 minutes on day 1 of weeks 1, 4, 7, and 10. Patients undergo RT beginning at week 13 for up to 6.5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.	Feasibility (VAC/VI/Temsirolimus) Patients receive vincristine sulfate IV over 1 minute on day 1 of weeks 1-13, 16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40, dactinomycin IV over 1-5 or 10-15 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, cyclophosphamide IV over 60 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, irinotecan hydrochloride IV over 90 minutes on days 1-5 of weeks 4, 10, 16, 19, 25, 31, and 37 and temsirolimus IV over 30-60 minutes on day 1 of weeks 1-12 and 21-42. Patients also undergo RT as in Regimen A. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients then receive vinorelbine IV over 6-10 minutes on days 1, 8, and 15 and cyclophosphamide PO QD on days 1-28. Cycles repeats every 28 days for 24 weeks in the absence of disease progression or unacceptable toxicity.
Overall Study STARTED	156	156	3	10
Overall Study COMPLETED	150	147	3	9
Overall Study NOT COMPLETED	6	9	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Regimen A (VAC/VI) Patients receive vincristine sulfate IV over 1 minute on day 1 of weeks 1-13, 16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40, dactinomycin IV over 1-5 or 10-15 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, cyclophosphamide IV over 60 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, irinotecan hydrochloride IV over 90 minutes on days 1-5 of weeks 4, 10, 16, 19, 25, 31, and 37. Patients also undergo primary site RT beginning at week 13 or metastatic site RT beginning at week 43 for up to 6.5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients then receive vinorelbine IV over 6-10 minutes on days 1, 8, and 15 and cyclophosphamide PO QD on days 1-28. Cycles repeats every 28 days for 24 weeks in the absence of disease progression or unacceptable toxicity.	Regimen B (VAC/VI/Temsirolimus) Patients receive vincristine sulfate IV over 1 minute on day 1 of weeks 1-13, 16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40, dactinomycin IV over 1-5 or 10-15 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, cyclophosphamide IV over 60 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, irinotecan hydrochloride IV over 90 minutes on days 1-5 of weeks 4, 10, 16, 19, 25, 31, and 37 and temsirolimus IV over 30-60 minutes on day 1 of weeks 1-12 and 21-42. Patients also undergo RT as in Regimen A. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients then receive vinorelbine IV over 6-10 minutes on days 1, 8, and 15 and cyclophosphamide PO QD on days 1-28. Cycles repeats every 28 days for 24 weeks in the absence of disease progression or unacceptable toxicity.	Feasibility (VAC/VI/Temsirolimus) Patients receive vincristine sulfate IV over 1 minute on day 1 of weeks 1-13, 16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40, dactinomycin IV over 1-5 or 10-15 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, cyclophosphamide IV over 60 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, irinotecan hydrochloride IV over 90 minutes on days 1-5 of weeks 4, 10, 16, 19, 25, 31, and 37 and temsirolimus IV over 30-60 minutes on day 1 of weeks 1-12 and 21-42. Patients also undergo RT as in Regimen A. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients then receive vinorelbine IV over 6-10 minutes on days 1, 8, and 15 and cyclophosphamide PO QD on days 1-28. Cycles repeats every 28 days for 24 weeks in the absence of disease progression or unacceptable toxicity.
Overall Study Death	1	1	0
Overall Study Ineligible	1	3	0
Overall Study Withdrawal of consent for any further data submissions	4	5	1

Baseline Characteristics

Combination Chemotherapy With or Without Temsirolimus in Treating Patients With Intermediate Risk Rhabdomyosarcoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Regimen A (VAC/VI) n=156 Participants Patients receive vincristine sulfate IV over 1 minute on day 1 of weeks 1-13, 16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40, dactinomycin IV over 1-5 or 10-15 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, cyclophosphamide IV over 60 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, irinotecan hydrochloride IV over 90 minutes on days 1-5 of weeks 4, 10, 16, 19, 25, 31, and 37. Patients also undergo primary site RT beginning at week 13 or metastatic site RT beginning at week 43 for up to 6.5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients then receive vinorelbine IV over 6-10 minutes on days 1, 8, and 15 and cyclophosphamide PO QD on days 1-28. Cycles repeats every 28 days for 24 weeks in the absence of disease progression or unacceptable toxicity.	Regimen B (VAC/VI/Temsirolimus) n=156 Participants Patients receive vincristine sulfate IV over 1 minute on day 1 of weeks 1-13, 16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40, dactinomycin IV over 1-5 or 10-15 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, cyclophosphamide IV over 60 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, irinotecan hydrochloride IV over 90 minutes on days 1-5 of weeks 4, 10, 16, 19, 25, 31, and 37 and temsirolimus IV over 30-60 minutes on day 1 of weeks 1-12 and 21-42. Patients also undergo RT as in Regimen A. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients then receive vinorelbine IV over 6-10 minutes on days 1, 8, and 15 and cyclophosphamide PO QD on days 1-28. Cycles repeats every 28 days for 24 weeks in the absence of disease progression or unacceptable toxicity.	Regimen C (FOXO1 Fusion Negative, VAC/VA) n=3 Participants Patients receive vincristine sulfate IV over 1 minute on day 1 of weeks 1-10 and 13-22, dactinomycin IV over 1-5 or 10-15 minutes on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, and 22, cyclophosphamide IV over 60 minutes on day 1 of weeks 1, 4, 7, and 10. Patients undergo RT beginning at week 13 for up to 6.5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.	Feasibility (VAC/VI/Temsirolimus) n=10 Participants Patients receive vincristine sulfate IV over 1 minute on day 1 of weeks 1-13, 16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40, dactinomycin IV over 1-5 or 10-15 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, cyclophosphamide IV over 60 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, irinotecan hydrochloride IV over 90 minutes on days 1-5 of weeks 4, 10, 16, 19, 25, 31, and 37 and temsirolimus IV over 30-60 minutes on day 1 of weeks 1-12 and 21-42. Patients also undergo RT as in Regimen A. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients then receive vinorelbine IV over 6-10 minutes on days 1, 8, and 15 and cyclophosphamide PO QD on days 1-28. Cycles repeats every 28 days for 24 weeks in the absence of disease progression or unacceptable toxicity.	Total n=325 Participants Total of all reporting groups
Age, Categorical <=18 years	145 Participants n=5 Participants	140 Participants n=20 Participants	3 Participants n=40 Participants	10 Participants n=28 Participants	298 Participants n=46 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants	16 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=28 Participants	27 Participants n=46 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=28 Participants	0 Participants n=46 Participants
Age, Continuous	6.57 years n=5 Participants	6.05 years n=20 Participants	5.71 years n=40 Participants	4.59 years n=28 Participants	6.34 years n=46 Participants
Sex: Female, Male Female	71 Participants n=5 Participants	55 Participants n=20 Participants	0 Participants n=40 Participants	3 Participants n=28 Participants	129 Participants n=46 Participants
Sex: Female, Male Male	85 Participants n=5 Participants	101 Participants n=20 Participants	3 Participants n=40 Participants	7 Participants n=28 Participants	196 Participants n=46 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	29 Participants n=5 Participants	17 Participants n=20 Participants	2 Participants n=40 Participants	1 Participants n=28 Participants	49 Participants n=46 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	113 Participants n=5 Participants	117 Participants n=20 Participants	1 Participants n=40 Participants	9 Participants n=28 Participants	240 Participants n=46 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	14 Participants n=5 Participants	22 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=28 Participants	36 Participants n=46 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=28 Participants	2 Participants n=46 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants	4 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=28 Participants	9 Participants n=46 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=28 Participants	1 Participants n=46 Participants
Race (NIH/OMB) Black or African American	20 Participants n=5 Participants	16 Participants n=20 Participants	0 Participants n=40 Participants	1 Participants n=28 Participants	37 Participants n=46 Participants
Race (NIH/OMB) White	99 Participants n=5 Participants	106 Participants n=20 Participants	2 Participants n=40 Participants	8 Participants n=28 Participants	215 Participants n=46 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants	3 Participants n=20 Participants	0 Participants n=40 Participants	1 Participants n=28 Participants	7 Participants n=46 Participants
Race (NIH/OMB) Unknown or Not Reported	27 Participants n=5 Participants	26 Participants n=20 Participants	1 Participants n=40 Participants	0 Participants n=28 Participants	54 Participants n=46 Participants
Region of Enrollment United States	141 participants n=5 Participants	135 participants n=20 Participants	3 participants n=40 Participants	10 participants n=28 Participants	289 participants n=46 Participants
Region of Enrollment Australia	6 participants n=5 Participants	11 participants n=20 Participants	0 participants n=40 Participants	0 participants n=28 Participants	17 participants n=46 Participants
Region of Enrollment Canada	6 participants n=5 Participants	9 participants n=20 Participants	0 participants n=40 Participants	0 participants n=28 Participants	15 participants n=46 Participants
Region of Enrollment New Zealand	3 participants n=5 Participants	1 participants n=20 Participants	0 participants n=40 Participants	0 participants n=28 Participants	4 participants n=46 Participants

PRIMARY outcome

Timeframe: Up to 3 years from study entry

Population: As pre-specified in the protocol, patients randomized to Regimen A (VAC/VI) and Regimen B (VAC/VI/Temsirolimus) were included in this analysis. The data was analyzed with revised intention-to-treat approach. Following patients were excluded 4 ineligible patients, 11 feasibility patients and 13 inevaluable patients (due to FOXO1 results or who did not receive maintenance therapy due to an amendment added during the study) .

Outcome measures

Outcome measures
Measure	Regimen A (VAC/VI) n=148 Participants Patients receive vincristine sulfate IV over 1 minute on day 1 of weeks 1-13, 16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40, dactinomycin IV over 1-5 or 10-15 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, cyclophosphamide IV over 60 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, irinotecan hydrochloride IV over 90 minutes on days 1-5 of weeks 4, 10, 16, 19, 25, 31, and 37. Patients also undergo primary site RT beginning at week 13 or metastatic site RT beginning at week 43 for up to 6.5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients then receive vinorelbine IV over 6-10 minutes on days 1, 8, and 15 and cyclophosphamide PO QD on days 1-28. Cycles repeats every 28 days for 24 weeks in the absence of disease progression or unacceptable toxicity.	Regimen B (VAC/VI/Temsirolimus) n=149 Participants Patients receive vincristine sulfate IV over 1 minute on day 1 of weeks 1-13, 16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40, dactinomycin IV over 1-5 or 10-15 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, cyclophosphamide IV over 60 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, irinotecan hydrochloride IV over 90 minutes on days 1-5 of weeks 4, 10, 16, 19, 25, 31, and 37 and temsirolimus IV over 30-60 minutes on day 1 of weeks 1-12 and 21-42. Patients also undergo RT as in Regimen A. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients then receive vinorelbine IV over 6-10 minutes on days 1, 8, and 15 and cyclophosphamide PO QD on days 1-28. Cycles repeats every 28 days for 24 weeks in the absence of disease progression or unacceptable toxicity.
Event-free Survival (EFS)	64.80 Percentage of participants Interval 55.5 to 74.1	66.80 Percentage of participants Interval 57.5 to 76.2

SECONDARY outcome

Timeframe: Up to 3 years from study entry

The Kaplan-Meier method will used to estimate 3-year OS between the randomized treatment groups (Regimen A (VAC/VI) vs. Regimen B (VAC/VI/Temsirolimus)) using the log-rank test. OS event is defined as the time from study entry until death.

Outcome measures

Outcome measures
Measure	Regimen A (VAC/VI) n=148 Participants Patients receive vincristine sulfate IV over 1 minute on day 1 of weeks 1-13, 16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40, dactinomycin IV over 1-5 or 10-15 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, cyclophosphamide IV over 60 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, irinotecan hydrochloride IV over 90 minutes on days 1-5 of weeks 4, 10, 16, 19, 25, 31, and 37. Patients also undergo primary site RT beginning at week 13 or metastatic site RT beginning at week 43 for up to 6.5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients then receive vinorelbine IV over 6-10 minutes on days 1, 8, and 15 and cyclophosphamide PO QD on days 1-28. Cycles repeats every 28 days for 24 weeks in the absence of disease progression or unacceptable toxicity.	Regimen B (VAC/VI/Temsirolimus) n=149 Participants Patients receive vincristine sulfate IV over 1 minute on day 1 of weeks 1-13, 16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40, dactinomycin IV over 1-5 or 10-15 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, cyclophosphamide IV over 60 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, irinotecan hydrochloride IV over 90 minutes on days 1-5 of weeks 4, 10, 16, 19, 25, 31, and 37 and temsirolimus IV over 30-60 minutes on day 1 of weeks 1-12 and 21-42. Patients also undergo RT as in Regimen A. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients then receive vinorelbine IV over 6-10 minutes on days 1, 8, and 15 and cyclophosphamide PO QD on days 1-28. Cycles repeats every 28 days for 24 weeks in the absence of disease progression or unacceptable toxicity.
Overall Survival (OS)	78.70 Percentage of participants Interval 70.9 to 86.4	77.80 Percentage of participants Interval 69.7 to 85.9

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 10 years

Will determine the frequency with which of ctDNA is detected in patients with intermediate-risk (IR) rhabdomyosarcoma (RMS) at diagnosis and how these levels change over time with. In addition, the level of ctDNA as a percent of total cell-free DNA will be summarized by reporting the median and range. Since no prior data are available on the rate of positivity nor the change over time, the analysis will be purely descriptive. Changes over time will be plotted to visually determine and compare the trajectories of ctDNA during the early and late stages of therapy.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 10 years

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: At week 9

Assessed by Deauville Criteria (5-point).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 10 years

The two-sample log-rank test will be performed.

Outcome measures

Outcome data not reported

Adverse Events

Regimen A (VAC/VI)

Serious events: 17 serious events

Other events: 139 other events

Deaths: 33 deaths

Regimen B (VAC/VI/Temsirolimus)

Serious events: 77 serious events

Other events: 141 other events

Deaths: 33 deaths

Regimen C (FOXO1 Fusion Negative, VAC/VA)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Feasibility (VAC/VI/Temsirolimus)

Serious events: 6 serious events

Other events: 8 other events

Deaths: 4 deaths

Serious adverse events

Other adverse events

Additional Information

Results Reporting Coordinator

Children's Oncology Group

Phone: 626-447-0064

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Serious adverse events
Measure	Regimen A (VAC/VI) n=155 participants at risk Patients receive vincristine sulfate IV over 1 minute on day 1 of weeks 1-13, 16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40, dactinomycin IV over 1-5 or 10-15 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, cyclophosphamide IV over 60 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, irinotecan hydrochloride IV over 90 minutes on days 1-5 of weeks 4, 10, 16, 19, 25, 31, and 37. Patients also undergo primary site RT beginning at week 13 or metastatic site RT beginning at week 43 for up to 6.5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients then receive vinorelbine IV over 6-10 minutes on days 1, 8, and 15 and cyclophosphamide PO QD on days 1-28. Cycles repeats every 28 days for 24 weeks in the absence of disease progression or unacceptable toxicity.	Regimen B (VAC/VI/Temsirolimus) n=153 participants at risk Patients receive vincristine sulfate IV over 1 minute on day 1 of weeks 1-13, 16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40, dactinomycin IV over 1-5 or 10-15 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, cyclophosphamide IV over 60 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, irinotecan hydrochloride IV over 90 minutes on days 1-5 of weeks 4, 10, 16, 19, 25, 31, and 37 and temsirolimus IV over 30-60 minutes on day 1 of weeks 1-12 and 21-42. Patients also undergo RT as in Regimen A. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients then receive vinorelbine IV over 6-10 minutes on days 1, 8, and 15 and cyclophosphamide PO QD on days 1-28. Cycles repeats every 28 days for 24 weeks in the absence of disease progression or unacceptable toxicity.	Regimen C (FOXO1 Fusion Negative, VAC/VA) n=3 participants at risk Patients receive vincristine sulfate IV over 1 minute on day 1 of weeks 1-10 and 13-22, dactinomycin IV over 1-5 or 10-15 minutes on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, and 22, cyclophosphamide IV over 60 minutes on day 1 of weeks 1, 4, 7, and 10. Patients undergo RT beginning at week 13 for up to 6.5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.	Feasibility (VAC/VI/Temsirolimus) n=10 participants at risk Patients receive vincristine sulfate IV over 1 minute on day 1 of weeks 1-13, 16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40, dactinomycin IV over 1-5 or 10-15 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, cyclophosphamide IV over 60 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, irinotecan hydrochloride IV over 90 minutes on days 1-5 of weeks 4, 10, 16, 19, 25, 31, and 37 and temsirolimus IV over 30-60 minutes on day 1 of weeks 1-12 and 21-42. Patients also undergo RT as in Regimen A. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients then receive vinorelbine IV over 6-10 minutes on days 1, 8, and 15 and cyclophosphamide PO QD on days 1-28. Cycles repeats every 28 days for 24 weeks in the absence of disease progression or unacceptable toxicity.
Infections and infestations Abdominal infection	0.00% 0/155 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	1.3% 2/153 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/3 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/10 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Gastrointestinal disorders Abdominal pain	0.65% 1/155 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/153 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/3 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/10 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Renal and urinary disorders Acute kidney injury	0.00% 0/155 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	2.0% 3/153 • Number of events 4 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/3 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/10 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Investigations Alanine aminotransferase increased	0.65% 1/155 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.65% 1/153 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/3 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/10 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Immune system disorders Allergic reaction	0.00% 0/155 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.65% 1/153 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/3 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/10 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Gastrointestinal disorders Anal mucositis	0.00% 0/155 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.65% 1/153 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/3 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/10 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Immune system disorders Anaphylaxis	0.00% 0/155 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/153 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/3 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	10.0% 1/10 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Blood and lymphatic system disorders Anemia	1.9% 3/155 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	3.9% 6/153 • Number of events 7 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/3 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/10 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Infections and infestations Anorectal infection	0.00% 0/155 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.65% 1/153 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/3 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/10 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Metabolism and nutrition disorders Anorexia	0.65% 1/155 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.65% 1/153 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/3 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/10 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Infections and infestations Appendicitis	0.00% 0/155 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.65% 1/153 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/3 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/10 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/155 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.65% 1/153 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/3 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/10 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Renal and urinary disorders Bladder spasm	0.00% 0/155 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.65% 1/153 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/3 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/10 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Investigations Blood bilirubin increased	0.00% 0/155 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.65% 1/153 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/3 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/10 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Infections and infestations Catheter related infection	0.65% 1/155 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	1.3% 2/153 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/3 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/10 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Gastrointestinal disorders Cecal hemorrhage	0.00% 0/155 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.65% 1/153 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/3 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/10 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Gastrointestinal disorders Colitis	0.00% 0/155 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	1.3% 2/153 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/3 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/10 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Gastrointestinal disorders Colonic obstruction	0.00% 0/155 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.65% 1/153 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/3 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/10 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Gastrointestinal disorders Constipation	0.65% 1/155 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.65% 1/153 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/3 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/10 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Investigations Creatinine increased	0.00% 0/155 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.65% 1/153 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/3 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/10 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Renal and urinary disorders Cystitis noninfective	0.00% 0/155 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.65% 1/153 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/3 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/10 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Immune system disorders Cytokine release syndrome	0.65% 1/155 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/153 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/3 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/10 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
General disorders Death NOS	0.65% 1/155 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/153 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/3 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/10 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Metabolism and nutrition disorders Dehydration	0.00% 0/155 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	8.5% 13/153 • Number of events 16 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/3 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	10.0% 1/10 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Psychiatric disorders Depression	0.65% 1/155 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/153 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/3 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/10 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Injury, poisoning and procedural complications Dermatitis radiation	0.00% 0/155 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/153 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/3 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	10.0% 1/10 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Gastrointestinal disorders Diarrhea	0.65% 1/155 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	4.6% 7/153 • Number of events 8 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/3 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	10.0% 1/10 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
General disorders Disease progression	0.00% 0/155 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.65% 1/153 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/3 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/10 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/155 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.65% 1/153 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/3 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/10 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Ear and labyrinth disorders Ear and labyrinth disorders - Other, specify	0.65% 1/155 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/153 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/3 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/10 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Gastrointestinal disorders Enterocolitis	0.00% 0/155 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	1.3% 2/153 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/3 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/10 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Infections and infestations Enterocolitis infectious	0.65% 1/155 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	1.3% 2/153 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/3 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/10 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/155 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.65% 1/153 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/3 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/10 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Eye disorders Eye disorders - Other, specify	0.00% 0/155 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	1.3% 2/153 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/3 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/10 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Blood and lymphatic system disorders Febrile neutropenia	1.3% 2/155 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	3.9% 6/153 • Number of events 9 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/3 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/10 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
General disorders Fever	0.00% 0/155 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	5.2% 8/153 • Number of events 11 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/3 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/10 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
General disorders Flu like symptoms	0.65% 1/155 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/153 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/3 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/10 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
General disorders Gait disturbance	0.65% 1/155 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/153 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/3 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/10 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Gastrointestinal disorders Gastric hemorrhage	0.00% 0/155 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	1.3% 2/153 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/3 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/10 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Gastrointestinal disorders Gastric ulcer	0.00% 0/155 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.65% 1/153 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/3 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/10 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.

Other adverse events
Measure	Regimen A (VAC/VI) n=155 participants at risk Patients receive vincristine sulfate IV over 1 minute on day 1 of weeks 1-13, 16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40, dactinomycin IV over 1-5 or 10-15 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, cyclophosphamide IV over 60 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, irinotecan hydrochloride IV over 90 minutes on days 1-5 of weeks 4, 10, 16, 19, 25, 31, and 37. Patients also undergo primary site RT beginning at week 13 or metastatic site RT beginning at week 43 for up to 6.5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients then receive vinorelbine IV over 6-10 minutes on days 1, 8, and 15 and cyclophosphamide PO QD on days 1-28. Cycles repeats every 28 days for 24 weeks in the absence of disease progression or unacceptable toxicity.	Regimen B (VAC/VI/Temsirolimus) n=153 participants at risk Patients receive vincristine sulfate IV over 1 minute on day 1 of weeks 1-13, 16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40, dactinomycin IV over 1-5 or 10-15 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, cyclophosphamide IV over 60 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, irinotecan hydrochloride IV over 90 minutes on days 1-5 of weeks 4, 10, 16, 19, 25, 31, and 37 and temsirolimus IV over 30-60 minutes on day 1 of weeks 1-12 and 21-42. Patients also undergo RT as in Regimen A. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients then receive vinorelbine IV over 6-10 minutes on days 1, 8, and 15 and cyclophosphamide PO QD on days 1-28. Cycles repeats every 28 days for 24 weeks in the absence of disease progression or unacceptable toxicity.	Regimen C (FOXO1 Fusion Negative, VAC/VA) n=3 participants at risk Patients receive vincristine sulfate IV over 1 minute on day 1 of weeks 1-10 and 13-22, dactinomycin IV over 1-5 or 10-15 minutes on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, and 22, cyclophosphamide IV over 60 minutes on day 1 of weeks 1, 4, 7, and 10. Patients undergo RT beginning at week 13 for up to 6.5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.	Feasibility (VAC/VI/Temsirolimus) n=10 participants at risk Patients receive vincristine sulfate IV over 1 minute on day 1 of weeks 1-13, 16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40, dactinomycin IV over 1-5 or 10-15 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, cyclophosphamide IV over 60 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, irinotecan hydrochloride IV over 90 minutes on days 1-5 of weeks 4, 10, 16, 19, 25, 31, and 37 and temsirolimus IV over 30-60 minutes on day 1 of weeks 1-12 and 21-42. Patients also undergo RT as in Regimen A. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients then receive vinorelbine IV over 6-10 minutes on days 1, 8, and 15 and cyclophosphamide PO QD on days 1-28. Cycles repeats every 28 days for 24 weeks in the absence of disease progression or unacceptable toxicity.
Gastrointestinal disorders Abdominal distension	1.9% 3/155 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	1.3% 2/153 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/3 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	10.0% 1/10 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Infections and infestations Abdominal infection	0.65% 1/155 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.65% 1/153 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/3 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/10 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Gastrointestinal disorders Abdominal pain	9.7% 15/155 • Number of events 23 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	19.0% 29/153 • Number of events 36 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/3 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/10 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Renal and urinary disorders Acute kidney injury	0.65% 1/155 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/153 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/3 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/10 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Psychiatric disorders Agitation	1.3% 2/155 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.65% 1/153 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/3 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/10 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Investigations Alanine aminotransferase increased	15.5% 24/155 • Number of events 31 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	25.5% 39/153 • Number of events 74 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/3 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/10 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Investigations Alkaline phosphatase increased	0.65% 1/155 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.65% 1/153 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/3 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/10 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Metabolism and nutrition disorders Alkalosis	1.3% 2/155 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/153 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/3 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/10 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Immune system disorders Allergic reaction	1.3% 2/155 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	4.6% 7/153 • Number of events 7 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/3 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/10 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	3.9% 6/155 • Number of events 7 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/153 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/3 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/10 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Skin and subcutaneous tissue disorders Alopecia	5.8% 9/155 • Number of events 9 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	9.2% 14/153 • Number of events 31 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/3 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/10 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Gastrointestinal disorders Anal fissure	0.00% 0/155 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	2.0% 3/153 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/3 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/10 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Gastrointestinal disorders Anal mucositis	0.65% 1/155 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.65% 1/153 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/3 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	10.0% 1/10 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Gastrointestinal disorders Anal pain	1.3% 2/155 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/153 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/3 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/10 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Immune system disorders Anaphylaxis	1.9% 3/155 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/153 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/3 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/10 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Blood and lymphatic system disorders Anemia	69.0% 107/155 • Number of events 417 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	76.5% 117/153 • Number of events 474 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	33.3% 1/3 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	30.0% 3/10 • Number of events 11 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Infections and infestations Anorectal infection	0.65% 1/155 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.65% 1/153 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/3 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/10 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Metabolism and nutrition disorders Anorexia	27.1% 42/155 • Number of events 68 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	27.5% 42/153 • Number of events 73 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/3 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	10.0% 1/10 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Psychiatric disorders Anxiety	1.9% 3/155 • Number of events 5 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	10.5% 16/153 • Number of events 17 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/3 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/10 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Respiratory, thoracic and mediastinal disorders Apnea	0.00% 0/155 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.65% 1/153 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/3 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/10 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/155 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	1.3% 2/153 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/3 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/10 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Gastrointestinal disorders Ascites	0.65% 1/155 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.65% 1/153 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/3 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/10 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Investigations Aspartate aminotransferase increased	6.5% 10/155 • Number of events 11 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	11.1% 17/153 • Number of events 34 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/3 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/10 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Respiratory, thoracic and mediastinal disorders Aspiration	0.65% 1/155 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.65% 1/153 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/3 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/10 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.65% 1/155 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	1.3% 2/153 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/3 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/10 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Musculoskeletal and connective tissue disorders Back pain	3.2% 5/155 • Number of events 5 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	3.9% 6/153 • Number of events 6 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/3 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/10 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Infections and infestations Bacteremia	1.3% 2/155 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	2.6% 4/153 • Number of events 4 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/3 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/10 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Infections and infestations Bladder infection	0.00% 0/155 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.65% 1/153 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/3 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/10 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Renal and urinary disorders Bladder spasm	1.9% 3/155 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	1.3% 2/153 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/3 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	10.0% 1/10 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Investigations Blood bilirubin increased	1.9% 3/155 • Number of events 9 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	2.6% 4/153 • Number of events 4 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/3 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/10 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Eye disorders Blurred vision	0.65% 1/155 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/153 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/3 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/10 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Musculoskeletal and connective tissue disorders Bone pain	0.65% 1/155 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.65% 1/153 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/3 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/10 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Infections and infestations Bronchial infection	0.00% 0/155 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	1.3% 2/153 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/3 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/10 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Injury, poisoning and procedural complications Bruising	0.00% 0/155 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.65% 1/153 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/3 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/10 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Injury, poisoning and procedural complications Burn	1.3% 2/155 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.65% 1/153 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/3 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/10 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Infections and infestations Catheter related infection	3.2% 5/155 • Number of events 7 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.65% 1/153 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/3 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	10.0% 1/10 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
General disorders Chills	0.00% 0/155 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.65% 1/153 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/3 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/10 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Investigations Cholesterol high	0.00% 0/155 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	1.3% 2/153 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/3 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/10 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Nervous system disorders Cognitive disturbance	0.65% 1/155 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/153 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/3 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/10 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Gastrointestinal disorders Colitis	3.9% 6/155 • Number of events 6 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	3.9% 6/153 • Number of events 6 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/3 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	10.0% 1/10 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.