Trial Outcomes & Findings for Combination Chemotherapy With or Without Ganitumab in Treating Patients With Newly Diagnosed Metastatic Ewing Sarcoma (NCT NCT02306161)

Last Updated: 2025-12-01

Results Overview

Estimated 5-year EFS where EFS is calculated as the time from study enrollment to disease progression, disease relapse, occurrence of a second malignant neoplasm, death from any cause or last follow-up whichever occurs first. Kaplan-Meier method is used for estimation. Patients without an event are censored at last contact.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE3

Target enrollment

312 participants

Primary outcome timeframe

5 years after enrollment

Results posted on

2025-12-01

Participant Flow

Participant milestones

Participant milestones
Measure	Regimen A (VDC/IE) INDUCTION THERAPY: Patients receive Induction therapy with alternating cycles of VDC and IE given every 2 weeks for 6 cycles. LOCAL CONTROL THERAPY: Between weeks 13-18, patients undergo surgery and/or radiation therapy. CONSOLIDATION THERAPY: Patients receive Consolidation therapy with alternating cycles of VDC and IE given every 2 weeks for 8 cycles. METASTATIC SITE IRRADIATION: Patients with lung metastases undergo whole lung radiation and patients with bone metastases undergo definitive SBRT or EBRT. Cyclophosphamide: Given IV Doxorubicin: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Etoposide Phosphate: Given IV External Beam Radiation Therapy: Undergo EBRT Ifosfamide: Given IV Stereotactic Radiosurgery: Undergo SBRT Therapeutic Surgical Procedure: Undergo surgery Vincristine: Given IV Vincristine Sulfate: Given IV	Regimen B (VDC/IE + Ganitumab) INDUCTION THERAPY: Patients receive Induction therapy as in Regimen A and receive ganitumab IV over 30-60 minutes or 60-120 minutes on day 1 of weeks 1, 3, 5, 7, 9, and 11. LOCAL CONTROL THERAPY: Between weeks 13-18, patients undergo surgery and/or radiation therapy. CONSOLIDATION THERAPY: Patients receive Consolidation therapy as in Regimen A and receive ganitumab IV over 30-60 minutes or 60-120 minutes on day 1 of weeks 7, 9, 11, 13, and 15. METASTATIC SITE IRRADIATION: Patients with lung metastases undergo whole lung radiation and patients with bone metastases undergo definitive SBRT or EBRT. MAINTENANCE: Patients receive ganitumab IV over 30-60 minutes or 60-120 minutes every 3 weeks for 8 cycles. Cyclophosphamide: Given IV Doxorubicin: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Etoposide Phosphate: Given IV External Beam Radiation Therapy: Undergo EBRT Ganitumab: Given IV Ifosfamide: Given IV Stereotactic Radiosurgery: Undergo SBRT Therapeutic Surgical Procedure: Undergo surgery Vincristine: Given IV Vincristine Sulfate: Given IV
Overall Study STARTED	157	155
Overall Study COMPLETED	93	86
Overall Study NOT COMPLETED	64	69

Reasons for withdrawal

Reasons for withdrawal
Measure	Regimen A (VDC/IE) INDUCTION THERAPY: Patients receive Induction therapy with alternating cycles of VDC and IE given every 2 weeks for 6 cycles. LOCAL CONTROL THERAPY: Between weeks 13-18, patients undergo surgery and/or radiation therapy. CONSOLIDATION THERAPY: Patients receive Consolidation therapy with alternating cycles of VDC and IE given every 2 weeks for 8 cycles. METASTATIC SITE IRRADIATION: Patients with lung metastases undergo whole lung radiation and patients with bone metastases undergo definitive SBRT or EBRT. Cyclophosphamide: Given IV Doxorubicin: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Etoposide Phosphate: Given IV External Beam Radiation Therapy: Undergo EBRT Ifosfamide: Given IV Stereotactic Radiosurgery: Undergo SBRT Therapeutic Surgical Procedure: Undergo surgery Vincristine: Given IV Vincristine Sulfate: Given IV	Regimen B (VDC/IE + Ganitumab) INDUCTION THERAPY: Patients receive Induction therapy as in Regimen A and receive ganitumab IV over 30-60 minutes or 60-120 minutes on day 1 of weeks 1, 3, 5, 7, 9, and 11. LOCAL CONTROL THERAPY: Between weeks 13-18, patients undergo surgery and/or radiation therapy. CONSOLIDATION THERAPY: Patients receive Consolidation therapy as in Regimen A and receive ganitumab IV over 30-60 minutes or 60-120 minutes on day 1 of weeks 7, 9, 11, 13, and 15. METASTATIC SITE IRRADIATION: Patients with lung metastases undergo whole lung radiation and patients with bone metastases undergo definitive SBRT or EBRT. MAINTENANCE: Patients receive ganitumab IV over 30-60 minutes or 60-120 minutes every 3 weeks for 8 cycles. Cyclophosphamide: Given IV Doxorubicin: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Etoposide Phosphate: Given IV External Beam Radiation Therapy: Undergo EBRT Ganitumab: Given IV Ifosfamide: Given IV Stereotactic Radiosurgery: Undergo SBRT Therapeutic Surgical Procedure: Undergo surgery Vincristine: Given IV Vincristine Sulfate: Given IV
Overall Study Death	1	3
Overall Study Lack of Efficacy	20	43
Overall Study Physician Decision	30	18
Overall Study Withdrawal by Subject	4	0
Overall Study Ineligible	9	5

Baseline Characteristics

Combination Chemotherapy With or Without Ganitumab in Treating Patients With Newly Diagnosed Metastatic Ewing Sarcoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Regimen A (VDC/IE) n=157 Participants INDUCTION THERAPY: Patients receive Induction therapy with alternating cycles of VDC and IE given every 2 weeks for 6 cycles. LOCAL CONTROL THERAPY: Between weeks 13-18, patients undergo surgery and/or radiation therapy. CONSOLIDATION THERAPY: Patients receive Consolidation therapy with alternating cycles of VDC and IE given every 2 weeks for 8 cycles. METASTATIC SITE IRRADIATION: Patients with lung metastases undergo whole lung radiation and patients with bone metastases undergo definitive SBRT or EBRT. Cyclophosphamide: Given IV Doxorubicin: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Etoposide Phosphate: Given IV External Beam Radiation Therapy: Undergo EBRT Ifosfamide: Given IV Stereotactic Radiosurgery: Undergo SBRT Therapeutic Surgical Procedure: Undergo surgery Vincristine: Given IV Vincristine Sulfate: Given IV	Regimen B (VDC/IE + Ganitumab) n=155 Participants INDUCTION THERAPY: Patients receive Induction therapy as in Regimen A and receive ganitumab IV over 30-60 minutes or 60-120 minutes on day 1 of weeks 1, 3, 5, 7, 9, and 11. LOCAL CONTROL THERAPY: Between weeks 13-18, patients undergo surgery and/or radiation therapy. CONSOLIDATION THERAPY: Patients receive Consolidation therapy as in Regimen A and receive ganitumab IV over 30-60 minutes or 60-120 minutes on day 1 of weeks 7, 9, 11, 13, and 15. METASTATIC SITE IRRADIATION: Patients with lung metastases undergo whole lung radiation and patients with bone metastases undergo definitive SBRT or EBRT. MAINTENANCE: Patients receive ganitumab IV over 30-60 minutes or 60-120 minutes every 3 weeks for 8 cycles. Cyclophosphamide: Given IV Doxorubicin: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Etoposide Phosphate: Given IV External Beam Radiation Therapy: Undergo EBRT Ganitumab: Given IV Ifosfamide: Given IV Stereotactic Radiosurgery: Undergo SBRT Therapeutic Surgical Procedure: Undergo surgery Vincristine: Given IV Vincristine Sulfate: Given IV	Total n=312 Participants Total of all reporting groups
Age, Categorical <=18 years	124 Participants n=121 Participants	123 Participants n=122 Participants	247 Participants n=243 Participants
Age, Categorical Between 18 and 65 years	33 Participants n=121 Participants	32 Participants n=122 Participants	65 Participants n=243 Participants
Age, Categorical >=65 years	0 Participants n=121 Participants	0 Participants n=122 Participants	0 Participants n=243 Participants
Age, Continuous	14.89 years n=121 Participants	15.16 years n=122 Participants	15.03 years n=243 Participants
Sex: Female, Male Female	71 Participants n=121 Participants	69 Participants n=122 Participants	140 Participants n=243 Participants
Sex: Female, Male Male	86 Participants n=121 Participants	86 Participants n=122 Participants	172 Participants n=243 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	28 Participants n=121 Participants	23 Participants n=122 Participants	51 Participants n=243 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	113 Participants n=121 Participants	116 Participants n=122 Participants	229 Participants n=243 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	16 Participants n=121 Participants	16 Participants n=122 Participants	32 Participants n=243 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=121 Participants	0 Participants n=122 Participants	1 Participants n=243 Participants
Race (NIH/OMB) Asian	4 Participants n=121 Participants	4 Participants n=122 Participants	8 Participants n=243 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=121 Participants	2 Participants n=122 Participants	2 Participants n=243 Participants
Race (NIH/OMB) Black or African American	5 Participants n=121 Participants	3 Participants n=122 Participants	8 Participants n=243 Participants
Race (NIH/OMB) White	128 Participants n=121 Participants	125 Participants n=122 Participants	253 Participants n=243 Participants
Race (NIH/OMB) More than one race	2 Participants n=121 Participants	0 Participants n=122 Participants	2 Participants n=243 Participants
Race (NIH/OMB) Unknown or Not Reported	17 Participants n=121 Participants	21 Participants n=122 Participants	38 Participants n=243 Participants
Region of Enrollment United States	144 participants n=121 Participants	142 participants n=122 Participants	286 participants n=243 Participants
Region of Enrollment Canada	10 participants n=121 Participants	11 participants n=122 Participants	21 participants n=243 Participants
Region of Enrollment China	0 participants n=121 Participants	1 participants n=122 Participants	1 participants n=243 Participants
Region of Enrollment Guatemala	1 participants n=121 Participants	0 participants n=122 Participants	1 participants n=243 Participants
Region of Enrollment Puerto Rico	2 participants n=121 Participants	1 participants n=122 Participants	3 participants n=243 Participants

PRIMARY outcome

Timeframe: 5 years after enrollment

Population: Only eligible patients are considered in the calculation of this outcome measure.

Outcome measures

Outcome measures
Measure	Regimen A (VDC/IE) n=148 Participants INDUCTION THERAPY: Patients receive Induction therapy with alternating cycles of VDC and IE given every 2 weeks for 6 cycles. LOCAL CONTROL THERAPY: Between weeks 13-18, patients undergo surgery and/or radiation therapy. CONSOLIDATION THERAPY: Patients receive Consolidation therapy with alternating cycles of VDC and IE given every 2 weeks for 8 cycles. METASTATIC SITE IRRADIATION: Patients with lung metastases undergo whole lung radiation and patients with bone metastases undergo definitive SBRT or EBRT. Cyclophosphamide: Given IV Doxorubicin: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Etoposide Phosphate: Given IV External Beam Radiation Therapy: Undergo EBRT Ifosfamide: Given IV Stereotactic Radiosurgery: Undergo SBRT Therapeutic Surgical Procedure: Undergo surgery Vincristine: Given IV Vincristine Sulfate: Given IV	Regimen B (VDC/IE + Ganitumab) n=150 Participants INDUCTION THERAPY: Patients receive Induction therapy as in Regimen A and receive ganitumab IV over 30-60 minutes or 60-120 minutes on day 1 of weeks 1, 3, 5, 7, 9, and 11. LOCAL CONTROL THERAPY: Between weeks 13-18, patients undergo surgery and/or radiation therapy. CONSOLIDATION THERAPY: Patients receive Consolidation therapy as in Regimen A and receive ganitumab IV over 30-60 minutes or 60-120 minutes on day 1 of weeks 7, 9, 11, 13, and 15. METASTATIC SITE IRRADIATION: Patients with lung metastases undergo whole lung radiation and patients with bone metastases undergo definitive SBRT or EBRT. MAINTENANCE: Patients receive ganitumab IV over 30-60 minutes or 60-120 minutes every 3 weeks for 8 cycles. Cyclophosphamide: Given IV Doxorubicin: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Etoposide Phosphate: Given IV External Beam Radiation Therapy: Undergo EBRT Ganitumab: Given IV Ifosfamide: Given IV Stereotactic Radiosurgery: Undergo SBRT Therapeutic Surgical Procedure: Undergo surgery Vincristine: Given IV Vincristine Sulfate: Given IV
Event-free Survival	30.88 percent probability of participants Interval 22.5 to 39.63	30.4 percent probability of participants Interval 22.4 to 38.88

SECONDARY outcome

Timeframe: 5 years after enrollment

Population: Only eligible patients are considered in the calculation of this outcome measure.

Time from study enrollment to death or last patient contact.

Outcome measures

Outcome measures
Measure	Regimen A (VDC/IE) n=148 Participants INDUCTION THERAPY: Patients receive Induction therapy with alternating cycles of VDC and IE given every 2 weeks for 6 cycles. LOCAL CONTROL THERAPY: Between weeks 13-18, patients undergo surgery and/or radiation therapy. CONSOLIDATION THERAPY: Patients receive Consolidation therapy with alternating cycles of VDC and IE given every 2 weeks for 8 cycles. METASTATIC SITE IRRADIATION: Patients with lung metastases undergo whole lung radiation and patients with bone metastases undergo definitive SBRT or EBRT. Cyclophosphamide: Given IV Doxorubicin: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Etoposide Phosphate: Given IV External Beam Radiation Therapy: Undergo EBRT Ifosfamide: Given IV Stereotactic Radiosurgery: Undergo SBRT Therapeutic Surgical Procedure: Undergo surgery Vincristine: Given IV Vincristine Sulfate: Given IV	Regimen B (VDC/IE + Ganitumab) n=150 Participants INDUCTION THERAPY: Patients receive Induction therapy as in Regimen A and receive ganitumab IV over 30-60 minutes or 60-120 minutes on day 1 of weeks 1, 3, 5, 7, 9, and 11. LOCAL CONTROL THERAPY: Between weeks 13-18, patients undergo surgery and/or radiation therapy. CONSOLIDATION THERAPY: Patients receive Consolidation therapy as in Regimen A and receive ganitumab IV over 30-60 minutes or 60-120 minutes on day 1 of weeks 7, 9, 11, 13, and 15. METASTATIC SITE IRRADIATION: Patients with lung metastases undergo whole lung radiation and patients with bone metastases undergo definitive SBRT or EBRT. MAINTENANCE: Patients receive ganitumab IV over 30-60 minutes or 60-120 minutes every 3 weeks for 8 cycles. Cyclophosphamide: Given IV Doxorubicin: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Etoposide Phosphate: Given IV External Beam Radiation Therapy: Undergo EBRT Ganitumab: Given IV Ifosfamide: Given IV Stereotactic Radiosurgery: Undergo SBRT Therapeutic Surgical Procedure: Undergo surgery Vincristine: Given IV Vincristine Sulfate: Given IV
Overall Survival	44.93 Percent Probability Interval 33.61 to 55.6	48.19 Percent Probability Interval 38.15 to 57.52

SECONDARY outcome

Timeframe: Up to 202 days

Population: Only eligible patients who received at least one dose of assigned protocol therapy are considered in the calculation of this outcome measure. Five hundred twenty-seven (527) reporting periods were contributed by patients enrolled on Regimen A; Five hundred seventy-six 576 reporting periods were contributed by patients enrolled on Regimen B.

The number of induction or consolidation reporting periods in which a CTC version 4 codeable grade 4 or greater non-hematological adverse event, grade 3 or greater left ventricular systolic dysfunction or the reporting period is terminated because of a CTC codeable event.

Outcome measures

Outcome measures
Measure	Regimen A (VDC/IE) n=527 Reporting Periods INDUCTION THERAPY: Patients receive Induction therapy with alternating cycles of VDC and IE given every 2 weeks for 6 cycles. LOCAL CONTROL THERAPY: Between weeks 13-18, patients undergo surgery and/or radiation therapy. CONSOLIDATION THERAPY: Patients receive Consolidation therapy with alternating cycles of VDC and IE given every 2 weeks for 8 cycles. METASTATIC SITE IRRADIATION: Patients with lung metastases undergo whole lung radiation and patients with bone metastases undergo definitive SBRT or EBRT. Cyclophosphamide: Given IV Doxorubicin: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Etoposide Phosphate: Given IV External Beam Radiation Therapy: Undergo EBRT Ifosfamide: Given IV Stereotactic Radiosurgery: Undergo SBRT Therapeutic Surgical Procedure: Undergo surgery Vincristine: Given IV Vincristine Sulfate: Given IV	Regimen B (VDC/IE + Ganitumab) n=576 Reporting Periods INDUCTION THERAPY: Patients receive Induction therapy as in Regimen A and receive ganitumab IV over 30-60 minutes or 60-120 minutes on day 1 of weeks 1, 3, 5, 7, 9, and 11. LOCAL CONTROL THERAPY: Between weeks 13-18, patients undergo surgery and/or radiation therapy. CONSOLIDATION THERAPY: Patients receive Consolidation therapy as in Regimen A and receive ganitumab IV over 30-60 minutes or 60-120 minutes on day 1 of weeks 7, 9, 11, 13, and 15. METASTATIC SITE IRRADIATION: Patients with lung metastases undergo whole lung radiation and patients with bone metastases undergo definitive SBRT or EBRT. MAINTENANCE: Patients receive ganitumab IV over 30-60 minutes or 60-120 minutes every 3 weeks for 8 cycles. Cyclophosphamide: Given IV Doxorubicin: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Etoposide Phosphate: Given IV External Beam Radiation Therapy: Undergo EBRT Ganitumab: Given IV Ifosfamide: Given IV Stereotactic Radiosurgery: Undergo SBRT Therapeutic Surgical Procedure: Undergo surgery Vincristine: Given IV Vincristine Sulfate: Given IV
Frequency of Toxicity-events	10 Reporting Periods	27 Reporting Periods

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 10 years

In addition to the log rank test the modeling approach will be used for the primary study comparison. Linear trend in EFS-risk will be investigated by segregating the marker level according to quartiles. For bone marrow response rate analyses, Fisher's exact test will be used to compare the objective bone marrow response rate (complete response vs. incomplete response) at start of local control between patients with biomarker levels above and below the group median.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 307 days

Extent of tumor cell IGF-1R co-expression will also be reported. Change in tumor cell IGF-1R co-expression in patients treated with and without ganitumab will be reported descriptively.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 10 years

EFS will be compared between patients with and without the presence of the minor allele using the log rank test, both for the entire patient population and for patients randomized to ganitumab.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 10 years

The institutional result of EWS tumor testing will be categorized as translocation detected (yes v. no) and the type of translocation detected will also be recorded. The proportion of patients with a particular EWS translocation variant will be tabulated.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 202 days

Will report the proportion of patients that have a change in translocation result associated with ctDNA testing across time periods.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 307 days

Will be identified by flow cytometry. Profiles will be presented graphically, and samples obtained from different sites of tumor within the same individual will also be presented.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 202 days

The number of induction and maintenance cycles received by patients randomized to the experimental therapy where SOS is observed. Only patients who receive all reporting period therapy or experience SOS will contribute to this outcome measure.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 84 days

The number of patients who are enrolled with bone marrow metastases whose bone marrow disease is not detected after evaluation at the time of of first local control measure or the end of the Induction reporting period, whichever comes first. Only eligible patients who receive at least one dose of randomized treatment assignment will be considered for this measure.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 307 days

The number of induction or consolidation reporting periods in which a CTC version 4 codeable non-hematological adverse event, grade 3 left ventricular systolic dysfunction or the reporting period is terminated because of a CTC codeable event.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 15 days

Trough levels of serum ganitumab prior to the second dose of ganitumab during induction obtained will be categorized as less than 10 micrograms per milliliter or greater than or equal to 10 micrograms per milliliter. This analysis will be conducted for the first 10 eligible patients who receive ganitumab.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 202 days

A patient who has SBRT planned for at least one metastatic site and receives successful SBRT treatment to at least 85% of metastatic sites in the treatment plan. Successful treatment is determined by IROC review criteria. Only eligible patients start the metastatic site radiation reporting period will be considered for this outcome measure.

Outcome measures

Outcome data not reported

Adverse Events

Regimen A (VDC/IE)

Serious events: 3 serious events

Other events: 114 other events

Deaths: 61 deaths

Regimen B (VDC/IE + Ganitumab)

Serious events: 45 serious events

Other events: 122 other events

Deaths: 67 deaths

Serious adverse events

Other adverse events

Additional Information

Results Reporting Coordinator

Children's Oncology Group

Phone: 16264470064

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 (VDC/IE) n=145 participants at risk INDUCTION THERAPY: Patients receive Induction therapy with alternating cycles of VDC and IE given every 2 weeks for 6 cycles. LOCAL CONTROL THERAPY: Between weeks 13-18, patients undergo surgery and/or radiation therapy. CONSOLIDATION THERAPY: Patients receive Consolidation therapy with alternating cycles of VDC and IE given every 2 weeks for 8 cycles. METASTATIC SITE IRRADIATION: Patients with lung metastases undergo whole lung radiation and patients with bone metastases undergo definitive SBRT or EBRT. Cyclophosphamide: Given IV Doxorubicin: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Etoposide Phosphate: Given IV External Beam Radiation Therapy: Undergo EBRT Ifosfamide: Given IV Stereotactic Radiosurgery: Undergo SBRT Therapeutic Surgical Procedure: Undergo surgery Vincristine: Given IV Vincristine Sulfate: Given IV	Regimen B (VDC/IE + Ganitumab) n=150 participants at risk INDUCTION THERAPY: Patients receive Induction therapy as in Regimen A and receive ganitumab IV over 30-60 minutes or 60-120 minutes on day 1 of weeks 1, 3, 5, 7, 9, and 11. LOCAL CONTROL THERAPY: Between weeks 13-18, patients undergo surgery and/or radiation therapy. CONSOLIDATION THERAPY: Patients receive Consolidation therapy as in Regimen A and receive ganitumab IV over 30-60 minutes or 60-120 minutes on day 1 of weeks 7, 9, 11, 13, and 15. METASTATIC SITE IRRADIATION: Patients with lung metastases undergo whole lung radiation and patients with bone metastases undergo definitive SBRT or EBRT. MAINTENANCE: Patients receive ganitumab IV over 30-60 minutes or 60-120 minutes every 3 weeks for 8 cycles. Cyclophosphamide: Given IV Doxorubicin: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Etoposide Phosphate: Given IV External Beam Radiation Therapy: Undergo EBRT Ganitumab: Given IV Ifosfamide: Given IV Stereotactic Radiosurgery: Undergo SBRT Therapeutic Surgical Procedure: Undergo surgery Vincristine: Given IV Vincristine Sulfate: Given IV
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/145 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.	4.0% 6/150 • Number of events 6 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.
Cardiac disorders Left ventricular systolic dysfunction	0.69% 1/145 • Number of events 1 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.	0.00% 0/150 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.
Cardiac disorders Sinus tachycardia	0.00% 0/145 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.	0.67% 1/150 • Number of events 1 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.
Gastrointestinal disorders Abdominal pain	0.69% 1/145 • Number of events 1 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.	2.0% 3/150 • Number of events 3 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.
Gastrointestinal disorders Colitis	0.00% 0/145 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.	0.67% 1/150 • Number of events 1 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.
Gastrointestinal disorders Colonic perforation	0.69% 1/145 • Number of events 1 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.	0.00% 0/150 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.
Gastrointestinal disorders Constipation	0.00% 0/145 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.	0.67% 1/150 • Number of events 1 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.
Gastrointestinal disorders Dysphagia	0.00% 0/145 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.	0.67% 1/150 • Number of events 1 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.
Gastrointestinal disorders Esophagitis	0.00% 0/145 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.	1.3% 2/150 • Number of events 2 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	0.00% 0/145 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.	0.67% 1/150 • Number of events 1 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.
Gastrointestinal disorders Ileus	0.00% 0/145 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.	0.67% 1/150 • Number of events 1 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.
Gastrointestinal disorders Mucositis oral	0.69% 1/145 • Number of events 1 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.	4.0% 6/150 • Number of events 6 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.
Gastrointestinal disorders Nausea	0.00% 0/145 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.	6.0% 9/150 • Number of events 9 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.
Gastrointestinal disorders Oral pain	0.00% 0/145 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.	1.3% 2/150 • Number of events 2 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.
Gastrointestinal disorders Rectal fistula	0.00% 0/145 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.	0.67% 1/150 • Number of events 1 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.
Gastrointestinal disorders Rectal mucositis	0.00% 0/145 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.	1.3% 2/150 • Number of events 2 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.
Gastrointestinal disorders Typhlitis	0.69% 1/145 • Number of events 1 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.	0.67% 1/150 • Number of events 1 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.
Gastrointestinal disorders Vomiting	0.00% 0/145 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.	4.0% 6/150 • Number of events 6 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.
General disorders Fever	0.69% 1/145 • Number of events 1 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.	1.3% 2/150 • Number of events 2 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.
Immune system disorders Allergic reaction	0.00% 0/145 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.	0.67% 1/150 • Number of events 1 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.
Immune system disorders Anaphylaxis	0.00% 0/145 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.	1.3% 2/150 • Number of events 2 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.
Infections and infestations Anorectal infection	0.00% 0/145 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.	0.67% 1/150 • Number of events 1 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.
Infections and infestations Appendicitis	0.00% 0/145 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.	0.67% 1/150 • Number of events 1 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.
Infections and infestations Infections and infestations - Other, specify	0.00% 0/145 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.	0.67% 1/150 • Number of events 1 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.
Infections and infestations Sepsis	0.69% 1/145 • Number of events 1 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.	0.00% 0/150 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.
Infections and infestations Skin infection	0.00% 0/145 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.	0.67% 1/150 • Number of events 1 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.
Injury, poisoning and procedural complications Fracture	0.00% 0/145 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.	0.67% 1/150 • Number of events 1 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.
Investigations Alanine aminotransferase increased	0.00% 0/145 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.	0.67% 1/150 • Number of events 1 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.
Investigations Aspartate aminotransferase increased	0.00% 0/145 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.	2.0% 3/150 • Number of events 3 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.
Investigations Ejection fraction decreased	0.69% 1/145 • Number of events 1 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.	0.00% 0/150 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.
Investigations Lipase increased	0.00% 0/145 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.	0.67% 1/150 • Number of events 1 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.
Investigations Lymphocyte count decreased	0.00% 0/145 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.	0.67% 1/150 • Number of events 1 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.
Investigations Neutrophil count decreased	0.00% 0/145 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.	2.7% 4/150 • Number of events 4 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.
Investigations Platelet count decreased	0.00% 0/145 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.	0.67% 1/150 • Number of events 1 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.
Investigations Weight loss	0.00% 0/145 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.	0.67% 1/150 • Number of events 1 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.
Investigations White blood cell decreased	0.00% 0/145 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.	2.7% 4/150 • Number of events 4 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.
Metabolism and nutrition disorders Anorexia	0.00% 0/145 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.	5.3% 8/150 • Number of events 8 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.
Metabolism and nutrition disorders Dehydration	0.00% 0/145 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.	2.0% 3/150 • Number of events 3 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.
Metabolism and nutrition disorders Hypoalbuminemia	0.00% 0/145 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.	0.67% 1/150 • Number of events 1 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.
Metabolism and nutrition disorders Hypocalcemia	0.00% 0/145 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.	1.3% 2/150 • Number of events 2 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.

Other adverse events
Measure	Regimen A (VDC/IE) n=145 participants at risk INDUCTION THERAPY: Patients receive Induction therapy with alternating cycles of VDC and IE given every 2 weeks for 6 cycles. LOCAL CONTROL THERAPY: Between weeks 13-18, patients undergo surgery and/or radiation therapy. CONSOLIDATION THERAPY: Patients receive Consolidation therapy with alternating cycles of VDC and IE given every 2 weeks for 8 cycles. METASTATIC SITE IRRADIATION: Patients with lung metastases undergo whole lung radiation and patients with bone metastases undergo definitive SBRT or EBRT. Cyclophosphamide: Given IV Doxorubicin: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Etoposide Phosphate: Given IV External Beam Radiation Therapy: Undergo EBRT Ifosfamide: Given IV Stereotactic Radiosurgery: Undergo SBRT Therapeutic Surgical Procedure: Undergo surgery Vincristine: Given IV Vincristine Sulfate: Given IV	Regimen B (VDC/IE + Ganitumab) n=150 participants at risk INDUCTION THERAPY: Patients receive Induction therapy as in Regimen A and receive ganitumab IV over 30-60 minutes or 60-120 minutes on day 1 of weeks 1, 3, 5, 7, 9, and 11. LOCAL CONTROL THERAPY: Between weeks 13-18, patients undergo surgery and/or radiation therapy. CONSOLIDATION THERAPY: Patients receive Consolidation therapy as in Regimen A and receive ganitumab IV over 30-60 minutes or 60-120 minutes on day 1 of weeks 7, 9, 11, 13, and 15. METASTATIC SITE IRRADIATION: Patients with lung metastases undergo whole lung radiation and patients with bone metastases undergo definitive SBRT or EBRT. MAINTENANCE: Patients receive ganitumab IV over 30-60 minutes or 60-120 minutes every 3 weeks for 8 cycles. Cyclophosphamide: Given IV Doxorubicin: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Etoposide Phosphate: Given IV External Beam Radiation Therapy: Undergo EBRT Ganitumab: Given IV Ifosfamide: Given IV Stereotactic Radiosurgery: Undergo SBRT Therapeutic Surgical Procedure: Undergo surgery Vincristine: Given IV Vincristine Sulfate: Given IV
Gastrointestinal disorders Anal fistula	0.00% 0/145 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.	0.67% 1/150 • Number of events 1 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.
Gastrointestinal disorders Anal pain	0.00% 0/145 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.	0.67% 1/150 • Number of events 1 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.
Gastrointestinal disorders Colitis	0.00% 0/145 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.	0.67% 1/150 • Number of events 1 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.
Gastrointestinal disorders Constipation	1.4% 2/145 • Number of events 2 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.	0.00% 0/150 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.
Blood and lymphatic system disorders Anemia	2.1% 3/145 • Number of events 3 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.	4.7% 7/150 • Number of events 7 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.
General disorders Pain	2.1% 3/145 • Number of events 3 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.	1.3% 2/150 • Number of events 2 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.
Blood and lymphatic system disorders Febrile neutropenia	26.2% 38/145 • Number of events 38 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.	33.3% 50/150 • Number of events 50 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.
Blood and lymphatic system disorders Leukocytosis	0.69% 1/145 • Number of events 1 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.	0.00% 0/150 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.
Cardiac disorders Sinus tachycardia	0.00% 0/145 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.	0.67% 1/150 • Number of events 1 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.
Eye disorders Papilledema	0.00% 0/145 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.	0.67% 1/150 • Number of events 1 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.
Gastrointestinal disorders Abdominal pain	1.4% 2/145 • Number of events 2 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.	2.0% 3/150 • Number of events 3 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.
Gastrointestinal disorders Diarrhea	0.00% 0/145 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.	0.67% 1/150 • Number of events 1 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.
Gastrointestinal disorders Enterocolitis	0.69% 1/145 • Number of events 1 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.	0.67% 1/150 • Number of events 1 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	0.00% 0/145 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.	0.67% 1/150 • Number of events 1 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.
Gastrointestinal disorders Hemorrhoids	0.69% 1/145 • Number of events 1 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.	0.67% 1/150 • Number of events 1 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.
Gastrointestinal disorders Mucositis oral	4.1% 6/145 • Number of events 6 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.	6.0% 9/150 • Number of events 9 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.
Gastrointestinal disorders Nausea	5.5% 8/145 • Number of events 8 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.	0.00% 0/150 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.
Gastrointestinal disorders Oral pain	0.00% 0/145 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.	0.67% 1/150 • Number of events 1 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.
Gastrointestinal disorders Pancreatitis	0.69% 1/145 • Number of events 1 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.	0.00% 0/150 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.
Gastrointestinal disorders Rectal mucositis	0.69% 1/145 • Number of events 1 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.	0.00% 0/150 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.
Gastrointestinal disorders Rectal pain	0.69% 1/145 • Number of events 1 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.	0.67% 1/150 • Number of events 1 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.
Gastrointestinal disorders Small intestinal obstruction	0.69% 1/145 • Number of events 1 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.	0.00% 0/150 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.
Gastrointestinal disorders Vomiting	2.8% 4/145 • Number of events 4 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.	1.3% 2/150 • Number of events 2 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.
General disorders Fever	0.69% 1/145 • Number of events 1 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.	0.00% 0/150 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.
General disorders Infusion related reaction	0.69% 1/145 • Number of events 1 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.	0.00% 0/150 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.
Immune system disorders Anaphylaxis	0.69% 1/145 • Number of events 1 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.	0.67% 1/150 • Number of events 1 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.
Infections and infestations Abdominal infection	0.69% 1/145 • Number of events 1 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.	0.00% 0/150 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.
Infections and infestations Bladder infection	0.00% 0/145 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.	0.67% 1/150 • Number of events 1 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.
Infections and infestations Enterocolitis infectious	0.69% 1/145 • Number of events 1 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.	0.00% 0/150 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.
Infections and infestations Infections and infestations - Other, specify	2.8% 4/145 • Number of events 4 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.	4.0% 6/150 • Number of events 6 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.
Infections and infestations Lymph gland infection	0.69% 1/145 • Number of events 1 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.	0.00% 0/150 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.
Infections and infestations Periorbital infection	0.00% 0/145 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.	0.67% 1/150 • Number of events 1 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.
Infections and infestations Pleural infection	0.69% 1/145 • Number of events 1 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.	0.00% 0/150 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.
Infections and infestations Sepsis	0.00% 0/145 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.	0.67% 1/150 • Number of events 1 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.
Infections and infestations Skin infection	1.4% 2/145 • Number of events 2 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.	1.3% 2/150 • Number of events 2 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.
Infections and infestations Soft tissue infection	0.69% 1/145 • Number of events 1 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.	0.00% 0/150 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.
Infections and infestations Upper respiratory infection	1.4% 2/145 • Number of events 2 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.	0.67% 1/150 • Number of events 1 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.
Infections and infestations Urinary tract infection	3.4% 5/145 • Number of events 5 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.	2.0% 3/150 • Number of events 3 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.
Infections and infestations Vaginal infection	0.69% 1/145 • Number of events 1 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.	0.00% 0/150 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.
Infections and infestations Wound infection	0.69% 1/145 • Number of events 1 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.	1.3% 2/150 • Number of events 2 • Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.