Trial Outcomes & Findings for hu14.18-Interleukin-2 Fusion Protein in Treating Young Patients With Recurrent or Refractory Neuroblastoma (NCT NCT00082758)

Last Updated: 2015-02-12

Results Overview

Response rate to hu14.18-Interleukin-2 in 3 separate strata of patients with recurrent or refractory neuroblastoma. Patients will have radiologic (CT/MRI) tumor and urine homovanillic acid (HVA)/vanillylmandelic acid (VMA) measurements. Patients with prior marrow involvement will have marrow assessments. Patients with MIBG+ (iodine-131-meta-iodobenzylguanidine) prior disease will have MIBG scans performed. For CT/MRI lesions, measureable disease is measured by the Response Evaluation Criteria In Solid Tumors (RECIST) from the National Cancer Institute. RECIST (v1.0) for target lesions: Complete Response (CR): Disappearance of all target lesions, Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

39 participants

Primary outcome timeframe

Up to 30 weeks

Results posted on

2015-02-12

Participant Flow

Participant milestones

Participant milestones
Measure	Disease Measurable by Standard Criteria(hu14.18-interleukin-2) Patients with residual/refractory neuroblastoma and readily measurable residual/refractory disease using standard radiographic criteria. Standard radiographic criteria for CT/MRI Lesions will use the definitions of measurable disease from the Response Evaluation Criteria In Solid Tumors (RECIST) from the National Cancer Institute. hu14.18-Interleukin-2 fusion protein : Given IV	Disease Eval by MIBG or BM Histology (hu14.18-interleukin-2) Patients with residual/refractory neuroblastoma with disease that is not measurable by standard radiographic criteria, but is evaluable by meta-iodobenzylguanidine (MIBG) scanning and/or by bone marrow (BM) histology. hu14.18-Interleukin-2 fusion protein : Given IV
Overall Study STARTED	15	24
Overall Study COMPLETED	0	7
Overall Study NOT COMPLETED	15	17

Reasons for withdrawal

Reasons for withdrawal
Measure	Disease Measurable by Standard Criteria(hu14.18-interleukin-2) Patients with residual/refractory neuroblastoma and readily measurable residual/refractory disease using standard radiographic criteria. Standard radiographic criteria for CT/MRI Lesions will use the definitions of measurable disease from the Response Evaluation Criteria In Solid Tumors (RECIST) from the National Cancer Institute. hu14.18-Interleukin-2 fusion protein : Given IV	Disease Eval by MIBG or BM Histology (hu14.18-interleukin-2) Patients with residual/refractory neuroblastoma with disease that is not measurable by standard radiographic criteria, but is evaluable by meta-iodobenzylguanidine (MIBG) scanning and/or by bone marrow (BM) histology. hu14.18-Interleukin-2 fusion protein : Given IV
Overall Study Adverse Event	0	2
Overall Study Lack of Efficacy	12	13
Overall Study Physician Decision	0	1
Overall Study Withdrawal by Subject	3	0
Overall Study Protocol Violation	0	1

Baseline Characteristics

hu14.18-Interleukin-2 Fusion Protein in Treating Young Patients With Recurrent or Refractory Neuroblastoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Disease Measurable by Standard Criteria(hu14.18-interleukin-2) n=15 Participants Patients with residual/refractory neuroblastoma and readily measurable residual/refractory disease using standard radiographic criteria. Standard radiographic criteria for CT/MRI Lesions will use the definitions of measurable disease from the Response Evaluation Criteria In Solid Tumors (RECIST) from the National Cancer Institute. hu14.18-Interleukin-2 fusion protein : Given IV	Disease Eval by MIBG or BM Histology (hu14.18-interleukin-2) n=24 Participants Patients with residual/refractory neuroblastoma with disease that is not measurable by standard radiographic criteria, but is evaluable by MIBG (iodine-131-meta-iodobenzylguanidine) scanning and/or by bone marrow histology. hu14.18-Interleukin-2 fusion protein : Given IV	Disease Identified by BM Immunohistochemistry Only Patients with residual/refractory neuroblastoma that do not have disease that is measurable by standard radiographic techniques or evaluable by MIBG (iodine-131-meta-iodobenzylguanidine) scanning or BM histology, however, disease is identified and quantified by BM immunohistochemistry (\>5 neuroblastoma cells per 1,000,000 nucleated marrow cells). hu14.18-Interleukin-2 fusion protein : Given IV	Total n=39 Participants Total of all reporting groups
Age, Categorical <=18 years	15 participants n=39 Participants	23 participants n=41 Participants	—	38 participants n=31 Participants
Age, Categorical Between 18 and 65 years	0 participants n=39 Participants	1 participants n=41 Participants	—	1 participants n=31 Participants
Age, Categorical >=65 years	0 participants n=39 Participants	0 participants n=41 Participants	—	0 participants n=31 Participants
Age, Continuous	5.98 years n=39 Participants	6.28 years n=41 Participants	—	6.16 years n=31 Participants
Gender Female	7 participants n=39 Participants	10 participants n=41 Participants	—	17 participants n=31 Participants
Gender Male	8 participants n=39 Participants	14 participants n=41 Participants	—	22 participants n=31 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 participants n=39 Participants	2 participants n=41 Participants	—	2 participants n=31 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 participants n=39 Participants	21 participants n=41 Participants	—	36 participants n=31 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 participants n=39 Participants	1 participants n=41 Participants	—	1 participants n=31 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 participants n=39 Participants	1 participants n=41 Participants	—	1 participants n=31 Participants
Race (NIH/OMB) Asian	0 participants n=39 Participants	1 participants n=41 Participants	—	1 participants n=31 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 participants n=39 Participants	0 participants n=41 Participants	—	0 participants n=31 Participants
Race (NIH/OMB) Black or African American	5 participants n=39 Participants	3 participants n=41 Participants	—	8 participants n=31 Participants
Race (NIH/OMB) White	9 participants n=39 Participants	18 participants n=41 Participants	—	27 participants n=31 Participants
Race (NIH/OMB) More than one race	0 participants n=39 Participants	0 participants n=41 Participants	—	0 participants n=31 Participants
Race (NIH/OMB) Unknown or Not Reported	1 participants n=39 Participants	1 participants n=41 Participants	—	2 participants n=31 Participants
Region of Enrollment United States	14 participants n=39 Participants	22 participants n=41 Participants	—	36 participants n=31 Participants
Region of Enrollment Canada	1 participants n=39 Participants	2 participants n=41 Participants	—	3 participants n=31 Participants

PRIMARY outcome

Timeframe: Up to 30 weeks

Population: Patients were evaluable for inclusion in the analysis of response if eligible, had an event (relapse, PD, death or secondary malignancy) any time after enrollment, or completed at least 2 courses of Irinotecan/Temozolomide therapy. Patients off therapy before completion of 2 courses by choice or toxicity were not evaluable for response analysis.

Outcome measures

Outcome measures
Measure	Disease Measurable by Standard Criteria(hu14.18-interleukin-2) n=13 Participants Patients with residual/refractory neuroblastoma and readily measurable residual/refractory disease using standard radiographic criteria. Standard radiographic criteria for CT/MRI Lesions will use the definitions of measurable disease from the Response Evaluation Criteria In Solid Tumors (RECIST) from the National Cancer Institute. hu14.18-Interleukin-2 fusion protein : Given IV	Disease Eval by MIBG or BM Histology (hu14.18-interleukin-2) n=23 Participants Patients with residual/refractory neuroblastoma with disease that is not measurable by standard radiographic criteria, but is evaluable by MIBG (meta-iodobenzylguanidine) scanning and/or by bone marrow histology. hu14.18-Interleukin-2 fusion protein : Given IV	Disease Identified by BM Immunohistochemistry Only Patients with residual/refractory neuroblastoma that do not have disease that is measurable by standard radiographic techniques or evaluable by MIBG (iodine-131-meta-iodobenzylguanidine) scanning or BM histology, however, disease is identified and quantified by BM immunohistochemistry (\>5 neuroblastoma cells per 1,000,000 nucleated marrow cells) hu14.18-Interleukin-2 fusion protein : Given IV
Number of Responders (Response Rate) Responder	0 participants	5 participants	—
Number of Responders (Response Rate) Non-responder	13 participants	18 participants	—

Adverse Events

Disease Measurable by Standard Criteria(hu14.18-interleukin-2)

Serious events: 13 serious events

Other events: 13 other events

Deaths: 0 deaths

Disease Eval by MIBG or BM Histology (hu14.18-interleukin-2)

Serious events: 21 serious events

Other events: 18 other events

Deaths: 0 deaths

Disease Identified by BM Immunohistochemistry Only

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 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 Must obtain prior Sponsor approval.
Publication restrictions are in place

Restriction type: OTHER

Serious adverse events
Measure	Disease Measurable by Standard Criteria(hu14.18-interleukin-2) n=15 participants at risk Patients with residual/refractory neuroblastoma and readily measurable residual/refractory disease using standard radiographic criteria. Standard radiographic criteria for CT/MRI Lesions will use the definitions of measurable disease from the Response Evaluation Criteria In Solid Tumors (RECIST) from the National Cancer Institute. hu14.18-Interleukin-2 fusion protein : Given IV	Disease Eval by MIBG or BM Histology (hu14.18-interleukin-2) n=24 participants at risk Patients with residual/refractory neuroblastoma with disease that is not measurable by standard radiographic criteria, but is evaluable by MIBG (iodine-131-meta-iodobenzylguanidine) scanning and/or by bone marrow histology. hu14.18-Interleukin-2 fusion protein : Given IV	Disease Identified by BM Immunohistochemistry Only Patients with residual/refractory neuroblastoma that do not have disease that is measurable by standard radiographic techniques or evaluable by MIBG (iodine-131-meta-iodobenzylguanidine) scanning or BM histology, however, disease is identified and quantified by BM immunohistochemistry (\>5 neuroblastoma cells per 1,000,000 nucleated marrow cells). hu14.18-Interleukin-2 fusion protein : Given IV
Reproductive system and breast disorders Pelvic pain	0.00% 0/15 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	4.2% 1/24 • Number of events 1 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	— 0/0 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Blood and lymphatic system disorders Anemia	20.0% 3/15 • Number of events 4 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	25.0% 6/24 • Number of events 10 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	— 0/0 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/15 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	4.2% 1/24 • Number of events 2 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	— 0/0 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Ear and labyrinth disorders Hearing impaired	6.7% 1/15 • Number of events 1 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	0.00% 0/24 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	— 0/0 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Gastrointestinal disorders Abdominal pain	0.00% 0/15 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	4.2% 1/24 • Number of events 1 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	— 0/0 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
General disorders Death NOS	6.7% 1/15 • Number of events 1 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	0.00% 0/24 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	— 0/0 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Immune system disorders Anaphylaxis	6.7% 1/15 • Number of events 1 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	12.5% 3/24 • Number of events 4 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	— 0/0 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Infections and infestations Bone infection	0.00% 0/15 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	4.2% 1/24 • Number of events 1 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	— 0/0 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Infections and infestations Catheter related infection	6.7% 1/15 • Number of events 1 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	16.7% 4/24 • Number of events 9 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	— 0/0 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Infections and infestations Infections and infestations	6.7% 1/15 • Number of events 1 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	0.00% 0/24 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	— 0/0 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Infections and infestations Lung infection	0.00% 0/15 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	4.2% 1/24 • Number of events 1 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	— 0/0 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Infections and infestations Tooth infection	0.00% 0/15 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	4.2% 1/24 • Number of events 1 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	— 0/0 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Investigations Alanine aminotransferase	26.7% 4/15 • Number of events 5 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	16.7% 4/24 • Number of events 6 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	— 0/0 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Investigations Aspartate aminotransferase	26.7% 4/15 • Number of events 5 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	20.8% 5/24 • Number of events 7 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	— 0/0 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Investigations Blood bilirubin increased	13.3% 2/15 • Number of events 3 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	25.0% 6/24 • Number of events 8 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	— 0/0 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Investigations GGT increased	0.00% 0/15 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	4.2% 1/24 • Number of events 1 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	— 0/0 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Investigations Lymphocyte count decrease	26.7% 4/15 • Number of events 8 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	45.8% 11/24 • Number of events 33 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	— 0/0 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Investigations Neutrophil count decreased	33.3% 5/15 • Number of events 5 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	33.3% 8/24 • Number of events 20 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	— 0/0 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Investigations Platelet count decreased	33.3% 5/15 • Number of events 6 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	45.8% 11/24 • Number of events 27 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	— 0/0 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Investigations White blood cell decrease	13.3% 2/15 • Number of events 3 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	29.2% 7/24 • Number of events 12 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	— 0/0 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Metabolism and nutrition disorders Anorexia	0.00% 0/15 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	4.2% 1/24 • Number of events 2 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	— 0/0 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Metabolism and nutrition disorders Dehydration	0.00% 0/15 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	4.2% 1/24 • Number of events 1 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	— 0/0 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Metabolism and nutrition disorders Hyperglycemia	6.7% 1/15 • Number of events 1 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	0.00% 0/24 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	— 0/0 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Metabolism and nutrition disorders Hypoalbuminemia	6.7% 1/15 • Number of events 1 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	0.00% 0/24 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	— 0/0 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Metabolism and nutrition disorders Hypokalemia	6.7% 1/15 • Number of events 1 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	12.5% 3/24 • Number of events 4 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	— 0/0 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Metabolism and nutrition disorders Hyponatremia	6.7% 1/15 • Number of events 1 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	4.2% 1/24 • Number of events 1 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	— 0/0 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Metabolism and nutrition disorders Hypophosphatemia	6.7% 1/15 • Number of events 1 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	0.00% 0/24 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	— 0/0 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Nervous system disorders Dizziness	0.00% 0/15 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	4.2% 1/24 • Number of events 1 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	— 0/0 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Psychiatric disorders Agitation	0.00% 0/15 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	4.2% 1/24 • Number of events 1 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	— 0/0 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/15 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	4.2% 1/24 • Number of events 1 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	— 0/0 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/15 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	4.2% 1/24 • Number of events 1 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	— 0/0 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Respiratory, thoracic and mediastinal disorders Pleural effusion	6.7% 1/15 • Number of events 1 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	4.2% 1/24 • Number of events 1 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	— 0/0 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/15 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	8.3% 2/24 • Number of events 2 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	— 0/0 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/15 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	4.2% 1/24 • Number of events 1 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	— 0/0 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Vascular disorders Hypotension	0.00% 0/15 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	4.2% 1/24 • Number of events 1 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	— 0/0 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.

Other adverse events
Measure	Disease Measurable by Standard Criteria(hu14.18-interleukin-2) n=15 participants at risk Patients with residual/refractory neuroblastoma and readily measurable residual/refractory disease using standard radiographic criteria. Standard radiographic criteria for CT/MRI Lesions will use the definitions of measurable disease from the Response Evaluation Criteria In Solid Tumors (RECIST) from the National Cancer Institute. hu14.18-Interleukin-2 fusion protein : Given IV	Disease Eval by MIBG or BM Histology (hu14.18-interleukin-2) n=24 participants at risk Patients with residual/refractory neuroblastoma with disease that is not measurable by standard radiographic criteria, but is evaluable by MIBG (iodine-131-meta-iodobenzylguanidine) scanning and/or by bone marrow histology. hu14.18-Interleukin-2 fusion protein : Given IV	Disease Identified by BM Immunohistochemistry Only Patients with residual/refractory neuroblastoma that do not have disease that is measurable by standard radiographic techniques or evaluable by MIBG (iodine-131-meta-iodobenzylguanidine) scanning or BM histology, however, disease is identified and quantified by BM immunohistochemistry (\>5 neuroblastoma cells per 1,000,000 nucleated marrow cells). hu14.18-Interleukin-2 fusion protein : Given IV
Blood and lymphatic system disorders Anemia	73.3% 11/15 • Number of events 23 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	58.3% 14/24 • Number of events 42 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	— 0/0 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Cardiac disorders Cardiac disorders - Other	0.00% 0/15 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	8.3% 2/24 • Number of events 2 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	— 0/0 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Cardiac disorders Sinus tachycardia	6.7% 1/15 • Number of events 1 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	29.2% 7/24 • Number of events 16 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	— 0/0 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Ear and labyrinth disorders Middle ear inflammation	6.7% 1/15 • Number of events 1 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	0.00% 0/24 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	— 0/0 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Gastrointestinal disorders Abdominal pain	13.3% 2/15 • Number of events 2 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	0.00% 0/24 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	— 0/0 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Gastrointestinal disorders Ascites	13.3% 2/15 • Number of events 2 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	0.00% 0/24 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	— 0/0 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Gastrointestinal disorders Constipation	0.00% 0/15 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	12.5% 3/24 • Number of events 4 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	— 0/0 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Gastrointestinal disorders Diarrhea	6.7% 1/15 • Number of events 2 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	25.0% 6/24 • Number of events 10 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	— 0/0 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Gastrointestinal disorders Nausea	13.3% 2/15 • Number of events 2 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	0.00% 0/24 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	— 0/0 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Gastrointestinal disorders Vomiting	13.3% 2/15 • Number of events 3 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	33.3% 8/24 • Number of events 18 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	— 0/0 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
General disorders Chills	6.7% 1/15 • Number of events 1 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	0.00% 0/24 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	— 0/0 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
General disorders Edema face	20.0% 3/15 • Number of events 3 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	37.5% 9/24 • Number of events 17 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	— 0/0 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
General disorders Edema limbs	20.0% 3/15 • Number of events 5 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	8.3% 2/24 • Number of events 5 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	— 0/0 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
General disorders Edema trunk	6.7% 1/15 • Number of events 1 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	12.5% 3/24 • Number of events 4 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	— 0/0 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
General disorders Fever	6.7% 1/15 • Number of events 1 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	0.00% 0/24 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	— 0/0 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
General disorders Localized edema	6.7% 1/15 • Number of events 1 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	0.00% 0/24 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	— 0/0 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Infections and infestations Otitis media	0.00% 0/15 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	8.3% 2/24 • Number of events 2 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	— 0/0 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Infections and infestations Pharyngitis	0.00% 0/15 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	8.3% 2/24 • Number of events 2 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	— 0/0 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Infections and infestations Sinusitis	6.7% 1/15 • Number of events 1 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	0.00% 0/24 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	— 0/0 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Infections and infestations Upper respiratory infection	6.7% 1/15 • Number of events 1 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	0.00% 0/24 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	— 0/0 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Injury, poisoning and procedural complications Bruising	6.7% 1/15 • Number of events 1 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	0.00% 0/24 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	— 0/0 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Investigations Alanine aminotransferase	66.7% 10/15 • Number of events 20 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	58.3% 14/24 • Number of events 41 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	— 0/0 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Investigations Alkaline phosphatase increased	13.3% 2/15 • Number of events 2 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	20.8% 5/24 • Number of events 7 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	— 0/0 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Investigations Aspartate aminotransferase	60.0% 9/15 • Number of events 17 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	62.5% 15/24 • Number of events 44 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	— 0/0 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Investigations Blood bilirubin increased	60.0% 9/15 • Number of events 13 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	37.5% 9/24 • Number of events 22 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	— 0/0 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Investigations Cholesterol high	6.7% 1/15 • Number of events 2 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	0.00% 0/24 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	— 0/0 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Investigations Creatinine increased	20.0% 3/15 • Number of events 6 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	16.7% 4/24 • Number of events 6 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	— 0/0 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Investigations GGT increased	6.7% 1/15 • Number of events 2 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	16.7% 4/24 • Number of events 9 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	— 0/0 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Investigations Investigations - Other	0.00% 0/15 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	8.3% 2/24 • Number of events 26 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	— 0/0 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Investigations Lymphocyte count decrease	6.7% 1/15 • Number of events 1 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	16.7% 4/24 • Number of events 8 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	— 0/0 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Investigations Neutrophil count decreased	33.3% 5/15 • Number of events 6 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	25.0% 6/24 • Number of events 14 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	— 0/0 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Investigations Platelet count decreased	53.3% 8/15 • Number of events 17 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	45.8% 11/24 • Number of events 22 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	— 0/0 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Investigations Weight gain	20.0% 3/15 • Number of events 3 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	25.0% 6/24 • Number of events 12 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	— 0/0 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Investigations White blood cell decrease	60.0% 9/15 • Number of events 16 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	41.7% 10/24 • Number of events 32 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	— 0/0 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Metabolism and nutrition disorders Acidosis	13.3% 2/15 • Number of events 2 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	12.5% 3/24 • Number of events 4 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	— 0/0 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Metabolism and nutrition disorders Anorexia	26.7% 4/15 • Number of events 4 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	12.5% 3/24 • Number of events 8 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	— 0/0 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Metabolism and nutrition disorders Dehydration	6.7% 1/15 • Number of events 1 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	0.00% 0/24 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	— 0/0 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Metabolism and nutrition disorders Hypercalcemia	6.7% 1/15 • Number of events 1 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	0.00% 0/24 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	— 0/0 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Metabolism and nutrition disorders Hyperglycemia	46.7% 7/15 • Number of events 13 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	54.2% 13/24 • Number of events 26 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	— 0/0 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Metabolism and nutrition disorders Hyperkalemia	6.7% 1/15 • Number of events 1 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	8.3% 2/24 • Number of events 2 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.	— 0/0 • Duration of protocol therapy Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.