Trial Outcomes & Findings for Irinotecan Hydrochloride and Temozolomide With Temsirolimus or Dinutuximab in Treating Younger Patients With Refractory or Relapsed Neuroblastoma (NCT NCT01767194)

Last Updated: 2022-10-24

Results Overview

The percentage of patients who are responders will be tabulated, including a 95% confidence interval on the response rate. Responders are defined as patients who achieve a best overall response of complete response (CR), very good partial response (VGPR), or partial response (PR) per the International Neuroblastoma Response Criteria (INRC). Per INRC: CR= Disappearance of all target lesions. No evidence of tumor at any site; VGPR= \>90% decrease of the disease measurement for CT/MRI target lesions. All pre-existing bone lesions with CR by MIBG; MIBG scan can be stable disease (SD) or CR in soft tissue lesions corresponding to lesions on CT/MRI. CR in bone marrow. No new sites of tumor; PR= \>=30% decrease in the disease measurement for CT/MRI target lesions. Bone marrow with CR. MIBG with either PR/CR in bone lesions; MIBG may be SD or CR in soft tissue lesions corresponding to lesions on CT/MRI. Homovanillic acid (HVA)/Vanillylmandelic acid (VMA) may still be elevated.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

73 participants

Primary outcome timeframe

Up to the first 6 cycles of treatment

Results posted on

2022-10-24

Participant Flow

Participant milestones

Participant milestones
Measure	Arm I (Temozolomide, Irinotecan Hydrochloride, Temsirolimus) CLOSED TO ACCRUAL 06/17/2016 Patients receive temozolomide PO on days 1-5, irinotecan hydrochloride IV over 90 minutes on days 1-5, and temsirolimus IV over 30 minutes on days 1 and 8. Irinotecan Hydrochloride: Given IV Laboratory Biomarker Analysis: Optional correlative studies Temozolomide: Given PO Temsirolimus: Given IV	Arm II (Temozolomide, Irinotecan Hydrochloride, Dinutuximab) Patients receive temozolomide PO on days 1-5, irinotecan hydrochloride over 90 minutes on days 1-5, dinutuximab IV over 10-20 hours on days 2-5, and sargramostim SC or IV over 2 hours on days 6-12. Dinutuximab: Given IV Irinotecan Hydrochloride: Given IV Laboratory Biomarker Analysis: Optional correlative studies Sargramostim: Given SC or IV Temozolomide: Given PO
Overall Study STARTED	19	54
Overall Study COMPLETED	1	11
Overall Study NOT COMPLETED	18	43

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm I (Temozolomide, Irinotecan Hydrochloride, Temsirolimus) CLOSED TO ACCRUAL 06/17/2016 Patients receive temozolomide PO on days 1-5, irinotecan hydrochloride IV over 90 minutes on days 1-5, and temsirolimus IV over 30 minutes on days 1 and 8. Irinotecan Hydrochloride: Given IV Laboratory Biomarker Analysis: Optional correlative studies Temozolomide: Given PO Temsirolimus: Given IV	Arm II (Temozolomide, Irinotecan Hydrochloride, Dinutuximab) Patients receive temozolomide PO on days 1-5, irinotecan hydrochloride over 90 minutes on days 1-5, dinutuximab IV over 10-20 hours on days 2-5, and sargramostim SC or IV over 2 hours on days 6-12. Dinutuximab: Given IV Irinotecan Hydrochloride: Given IV Laboratory Biomarker Analysis: Optional correlative studies Sargramostim: Given SC or IV Temozolomide: Given PO
Overall Study Adverse Event	1	1
Overall Study Death	0	1
Overall Study Lack of Efficacy	12	11
Overall Study Physician Decision	2	23
Overall Study Withdrawal by Subject	0	1
Overall Study Ineligible	1	1
Overall Study Refusal by patient/parent	2	4
Overall Study Criteria not met on time for next cycle	0	1

Baseline Characteristics

Irinotecan Hydrochloride and Temozolomide With Temsirolimus or Dinutuximab in Treating Younger Patients With Refractory or Relapsed Neuroblastoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I (Temozolomide, Irinotecan Hydrochloride, Temsirolimus) n=19 Participants CLOSED TO ACCRUAL 06/17/2016 Patients receive temozolomide PO on days 1-5, irinotecan hydrochloride IV over 90 minutes on days 1-5, and temsirolimus IV over 30 minutes on days 1 and 8. Irinotecan Hydrochloride: Given IV Laboratory Biomarker Analysis: Optional correlative studies Temozolomide: Given PO Temsirolimus: Given IV	Arm II (Temozolomide, Irinotecan Hydrochloride, Dinutuximab) n=54 Participants Patients receive temozolomide PO on days 1-5, irinotecan hydrochloride over 90 minutes on days 1-5, dinutuximab IV over 10-20 hours on days 2-5, and sargramostim SC or IV over 2 hours on days 6-12. Dinutuximab: Given IV Irinotecan Hydrochloride: Given IV Laboratory Biomarker Analysis: Optional correlative studies Sargramostim: Given SC or IV Temozolomide: Given PO	Total n=73 Participants Total of all reporting groups
Age, Categorical <=18 years	19 Participants n=5 Participants	54 Participants n=7 Participants	73 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	7.2 Years n=5 Participants	4.9 Years n=7 Participants	5.7 Years n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	21 Participants n=7 Participants	29 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	33 Participants n=7 Participants	44 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants	8 Participants n=7 Participants	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=5 Participants	43 Participants n=7 Participants	57 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	7 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants	36 Participants n=7 Participants	50 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants	45 participants n=7 Participants	60 participants n=5 Participants
Region of Enrollment Canada	2 participants n=5 Participants	5 participants n=7 Participants	7 participants n=5 Participants
Region of Enrollment Australia	2 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants
Region of Enrollment New Zealand	0 participants n=5 Participants	2 participants n=7 Participants	2 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to the first 6 cycles of treatment

Population: Includes all eligible patients randomly assigned to Arm I or Arm II. Of the 19 participants randomized to Arm I, one was ineligible and not included in the analysis. Of the 54 participants assigned to Arm II, 1 was ineligible and 36 were non-randomly assigned, and not included in the analysis.

Outcome measures

Outcome measures
Measure	Arm I (Temozolomide, Irinotecan Hydrochloride, Temsirolimus) n=18 Participants CLOSED TO ACCRUAL 06/17/2016 Patients receive temozolomide PO on days 1-5, irinotecan hydrochloride IV over 90 minutes on days 1-5, and temsirolimus IV over 30 minutes on days 1 and 8. Irinotecan Hydrochloride: Given IV Laboratory Biomarker Analysis: Optional correlative studies Temozolomide: Given PO Temsirolimus: Given IV	Arm II (Temozolomide, Irinotecan Hydrochloride, Dinutuximab) n=17 Participants Patients receive temozolomide PO on days 1-5, irinotecan hydrochloride over 90 minutes on days 1-5, dinutuximab IV over 10-20 hours on days 2-5, and sargramostim SC or IV over 2 hours on days 6-12. Dinutuximab: Given IV Irinotecan Hydrochloride: Given IV Laboratory Biomarker Analysis: Optional correlative studies Sargramostim: Given SC or IV Temozolomide: Given PO
Percentage of Randomized Patients Who Are Responders	5.6 Percentage of patients Interval 0.0 to 16.1	52.9 Percentage of patients Interval 29.2 to 76.7

PRIMARY outcome

Timeframe: Up to the first 6 cycles of treatment

Population: Includes all eligible patients either randomized or non-randomly assigned to Arm II. Of the 54 participants assigned to Arm II, 1 was ineligible and not included in the analysis. The remaining 53 eligible participants are included in the analysis, 17 randomized and 36 non-randomly assigned to Arm II.

Percentage of patients who are responders to therapy with dinutuximab will be tabulated, including a 95% confidence interval on the response rate. Responders are defined as patients who achieve a best overall response of complete response (CR), very good partial response (VGPR), or partial response (PR) per the International Neuroblastoma Response Criteria (INRC). Per INRC: CR= Disappearance of all target lesions. No evidence of tumor at any site; VGPR= \>90% decrease of disease measurement for CT/MRI target lesions. All pre-existing bone lesions with CR by MIBG; MIBG scan can be stable disease (SD) or CR in soft tissue lesions corresponding to lesions on CT/MRI. CR in bone marrow. No new sites of tumor; PR= ≥30% decrease in disease measurement for CT/MRI target lesions. Bone marrow with CR. MIBG with either PR/CR in bone lesions; MIBG may be SD or CR in soft tissue lesions corresponding to lesions on CT/MRI. Homovanillic acid (HVA)/ Vanillylmandelic acid (VMA) may still be elevated.

Outcome measures

Outcome measures
Measure	Arm I (Temozolomide, Irinotecan Hydrochloride, Temsirolimus) n=53 Participants CLOSED TO ACCRUAL 06/17/2016 Patients receive temozolomide PO on days 1-5, irinotecan hydrochloride IV over 90 minutes on days 1-5, and temsirolimus IV over 30 minutes on days 1 and 8. Irinotecan Hydrochloride: Given IV Laboratory Biomarker Analysis: Optional correlative studies Temozolomide: Given PO Temsirolimus: Given IV	Arm II (Temozolomide, Irinotecan Hydrochloride, Dinutuximab) Patients receive temozolomide PO on days 1-5, irinotecan hydrochloride over 90 minutes on days 1-5, dinutuximab IV over 10-20 hours on days 2-5, and sargramostim SC or IV over 2 hours on days 6-12. Dinutuximab: Given IV Irinotecan Hydrochloride: Given IV Laboratory Biomarker Analysis: Optional correlative studies Sargramostim: Given SC or IV Temozolomide: Given PO
Percentage of Patients in the Dinutuximab Arm Who Are Responders	41.2 Percentage of patients Interval 28.2 to 54.8	—

Adverse Events

Arm I (Temozolomide, Irinotecan Hydrochloride, Temsirolimus)

Serious events: 5 serious events

Other events: 10 other events

Deaths: 12 deaths

Arm II (Temozolomide, Irinotecan Hydrochloride, Dinutuximab)

Serious events: 18 serious events

Other events: 39 other events

Deaths: 15 deaths

Serious adverse events

Other adverse events

Additional Information

Results Reporting Coordinator

Children's Oncology Group

Phone: 626-447-0064

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Serious adverse events
Measure	Arm I (Temozolomide, Irinotecan Hydrochloride, Temsirolimus) n=18 participants at risk CLOSED TO ACCRUAL 06/17/2016 Patients receive temozolomide PO on days 1-5, irinotecan hydrochloride IV over 90 minutes on days 1-5, and temsirolimus IV over 30 minutes on days 1 and 8. Irinotecan Hydrochloride: Given IV Laboratory Biomarker Analysis: Optional correlative studies Temozolomide: Given PO Temsirolimus: Given IV	Arm II (Temozolomide, Irinotecan Hydrochloride, Dinutuximab) n=51 participants at risk Patients receive temozolomide PO on days 1-5, irinotecan hydrochloride over 90 minutes on days 1-5, dinutuximab IV over 10-20 hours on days 2-5, and sargramostim SC or IV over 2 hours on days 6-12. Dinutuximab: Given IV Irinotecan Hydrochloride: Given IV Laboratory Biomarker Analysis: Optional correlative studies Sargramostim: Given SC or IV Temozolomide: Given PO
Investigations Alanine aminotransferase increased	5.6% 1/18 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.	2.0% 1/51 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.
Immune system disorders Allergic reaction	5.6% 1/18 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.	0.00% 0/51 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.
Immune system disorders Anaphylaxis	0.00% 0/18 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.	2.0% 1/51 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.
Blood and lymphatic system disorders Anemia	5.6% 1/18 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.	3.9% 2/51 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.
Metabolism and nutrition disorders Anorexia	5.6% 1/18 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.	0.00% 0/51 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.
Investigations Aspartate aminotransferase increased	0.00% 0/18 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.	3.9% 2/51 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.
Infections and infestations BACTEREMIA - LINE INFECTIONS	0.00% 0/18 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.	2.0% 1/51 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.
Infections and infestations BLOOD	5.6% 1/18 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.	0.00% 0/51 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/18 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.	2.0% 1/51 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.
Investigations Creatinine increased	0.00% 0/18 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.	2.0% 1/51 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.
General disorders Death NOS	0.00% 0/18 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.	2.0% 1/51 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.
Metabolism and nutrition disorders Dehydration	11.1% 2/18 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.	2.0% 1/51 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.
Nervous system disorders Depressed level of consciousness	0.00% 0/18 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.	2.0% 1/51 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.
Gastrointestinal disorders Diarrhea	11.1% 2/18 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.	3.9% 2/51 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/18 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.	3.9% 2/51 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.
Blood and lymphatic system disorders Febrile neutropenia	11.1% 2/18 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.	0.00% 0/51 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.
General disorders Fever	5.6% 1/18 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.	2.0% 1/51 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.
Investigations GGT increased	5.6% 1/18 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.	2.0% 1/51 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.
Nervous system disorders Headache	0.00% 0/18 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.	2.0% 1/51 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.
Ear and labyrinth disorders Hearing impaired	0.00% 0/18 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.	2.0% 1/51 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.
Vascular disorders Hypertension	0.00% 0/18 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.	2.0% 1/51 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.
Metabolism and nutrition disorders Hypokalemia	5.6% 1/18 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.	0.00% 0/51 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.
Vascular disorders Hypotension	0.00% 0/18 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.	2.0% 1/51 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/18 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.	5.9% 3/51 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.
Injury, poisoning and procedural complications Infusion related reaction	5.6% 1/18 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.	0.00% 0/51 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.
Infections and infestations Mucosal infection	5.6% 1/18 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.	0.00% 0/51 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.
Gastrointestinal disorders Nausea	0.00% 0/18 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.	2.0% 1/51 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.
Investigations Neutrophil count decreased	5.6% 1/18 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.	7.8% 4/51 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.
Infections and infestations norovirus	0.00% 0/18 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.	2.0% 1/51 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.
General disorders Pain	0.00% 0/18 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.	2.0% 1/51 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.
Nervous system disorders Peripheral motor neuropathy	0.00% 0/18 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.	2.0% 1/51 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.
Investigations Platelet count decreased	5.6% 1/18 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.	0.00% 0/51 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.
Infections and infestations POSITIVE BLOOD CULTURES	5.6% 1/18 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.	0.00% 0/51 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.
Injury, poisoning and procedural complications Prolapse of intestinal stoma	0.00% 0/18 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.	2.0% 1/51 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.
Infections and infestations RSV	0.00% 0/18 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.	2.0% 1/51 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.
Infections and infestations Sepsis	0.00% 0/18 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.	2.0% 1/51 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.
Infections and infestations Small intestine infection	0.00% 0/18 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.	2.0% 1/51 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.
Infections and infestations Soft tissue infection	0.00% 0/18 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.	2.0% 1/51 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.
Eye disorders TEMPORARY VISION LOSS	0.00% 0/18 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.	2.0% 1/51 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	0.00% 0/18 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.	2.0% 1/51 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.

Other adverse events
Measure	Arm I (Temozolomide, Irinotecan Hydrochloride, Temsirolimus) n=18 participants at risk CLOSED TO ACCRUAL 06/17/2016 Patients receive temozolomide PO on days 1-5, irinotecan hydrochloride IV over 90 minutes on days 1-5, and temsirolimus IV over 30 minutes on days 1 and 8. Irinotecan Hydrochloride: Given IV Laboratory Biomarker Analysis: Optional correlative studies Temozolomide: Given PO Temsirolimus: Given IV	Arm II (Temozolomide, Irinotecan Hydrochloride, Dinutuximab) n=51 participants at risk Patients receive temozolomide PO on days 1-5, irinotecan hydrochloride over 90 minutes on days 1-5, dinutuximab IV over 10-20 hours on days 2-5, and sargramostim SC or IV over 2 hours on days 6-12. Dinutuximab: Given IV Irinotecan Hydrochloride: Given IV Laboratory Biomarker Analysis: Optional correlative studies Sargramostim: Given SC or IV Temozolomide: Given PO
Gastrointestinal disorders Abdominal pain	0.00% 0/18 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.	5.9% 3/51 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.
Investigations Activated partial thromboplastin time prolonged	0.00% 0/18 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.	2.0% 1/51 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.
Investigations Alanine aminotransferase increased	22.2% 4/18 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.	15.7% 8/51 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.
Immune system disorders Allergic reaction	0.00% 0/18 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.	2.0% 1/51 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.
Blood and lymphatic system disorders Anemia	27.8% 5/18 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.	23.5% 12/51 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.
Metabolism and nutrition disorders Anorexia	11.1% 2/18 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.	3.9% 2/51 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.
Investigations Aspartate aminotransferase increased	11.1% 2/18 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.	3.9% 2/51 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/18 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.	2.0% 1/51 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.
Infections and infestations BACTEREMIA	0.00% 0/18 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.	2.0% 1/51 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.
Infections and infestations BLOOD	5.6% 1/18 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.	0.00% 0/51 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.
Infections and infestations BLOOD - STAPHYLOCOCCUS EPIDERMIDIS ISOLATED.	0.00% 0/18 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.	2.0% 1/51 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.
Infections and infestations BLOOD - STAPHYLOCOCCUS HOMINIS ISOLATES	0.00% 0/18 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.	2.0% 1/51 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.
Investigations Blood bilirubin increased	5.6% 1/18 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.	0.00% 0/51 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.
Eye disorders Blurred vision	0.00% 0/18 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.	2.0% 1/51 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.
Vascular disorders Capillary leak syndrome	0.00% 0/18 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.	3.9% 2/51 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.
Cardiac disorders Cardiac arrest	0.00% 0/18 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.	2.0% 1/51 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.
Infections and infestations CENTRAL LINE INFECTION	0.00% 0/18 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.	2.0% 1/51 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/18 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.	2.0% 1/51 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.
Metabolism and nutrition disorders Dehydration	5.6% 1/18 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.	5.9% 3/51 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.
Psychiatric disorders Delirium	0.00% 0/18 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.	2.0% 1/51 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.
Gastrointestinal disorders Diarrhea	0.00% 0/18 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.	15.7% 8/51 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/18 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.	2.0% 1/51 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.
Gastrointestinal disorders Enterocolitis	0.00% 0/18 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.	2.0% 1/51 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.
Infections and infestations Enterocolitis infectious	0.00% 0/18 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.	2.0% 1/51 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.
General disorders Fatigue	5.6% 1/18 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.	2.0% 1/51 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.
Blood and lymphatic system disorders Febrile neutropenia	5.6% 1/18 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.	2.0% 1/51 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.
General disorders Fever	0.00% 0/18 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.	19.6% 10/51 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.
Investigations GGT increased	0.00% 0/18 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.	3.9% 2/51 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.
Infections and infestations GRAM-POSITIVE BACILLI FROM PORT BLOOD CULTURE	5.6% 1/18 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.	0.00% 0/51 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.
Metabolism and nutrition disorders Hyperglycemia	5.6% 1/18 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.	5.9% 3/51 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.
Metabolism and nutrition disorders Hyperkalemia	0.00% 0/18 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.	3.9% 2/51 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.
Metabolism and nutrition disorders Hypoalbuminemia	0.00% 0/18 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.	2.0% 1/51 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.
Metabolism and nutrition disorders Hypocalcemia	0.00% 0/18 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.	7.8% 4/51 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.
Metabolism and nutrition disorders Hypokalemia	22.2% 4/18 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.	17.6% 9/51 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.
Metabolism and nutrition disorders Hypomagnesemia	5.6% 1/18 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.	0.00% 0/51 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/18 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.	11.8% 6/51 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.
Metabolism and nutrition disorders Hypophosphatemia	5.6% 1/18 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.	2.0% 1/51 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.
Vascular disorders Hypotension	0.00% 0/18 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.	9.8% 5/51 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/18 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.	7.8% 4/51 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.
Infections and infestations INFECTION	0.00% 0/18 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.	2.0% 1/51 • Through completion of protocol therapy, up to approximately 1 year. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.