Trial Outcomes & Findings for Therapy for Children With Advanced Stage Neuroblastoma (NCT NCT01857934)

Last Updated: 2025-11-17

Results Overview

Per the 1993 INRC: measurable tumor defined as product of the longest x widest perpendicular diameter, elevated catecholamine levels and tumor cels in bone marrow. Complete Response (CR)-no evidence of primary tumor or metastases. Very Good Partial Response (VGPR)-\>90% reduction of primary tumor; no metastases; no new bone lesions, all pre-existing lesions improved. Partial Response (PR)-50-90% reduction of primary tumor; \>50% reduction in measurable sites of metastases; 0-1 bone marrow samples with tumor; number of positive bone sites decreased by \>50%. Mixed Response (MR)-\>50% reduction of any measurable lesion with \<50% reduction in other sites; no new lesions; \<25% increase in any existing lesion. No Response (NR)-no new lesions; \<50% reduction but \<25% increase in an any existing lesion. No Response (NR)-no new lesions; \<50% reduction but \<25% increase in any existing legions. Progressive Disease (PD)-any new/increased measurable lesion by \>25%; previous negative marrow positive.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

153 participants

Primary outcome timeframe

After two initial courses of chemotherapy (approximately 6 weeks after enrollment)

Results posted on

2025-11-17

Participant Flow

A total of 153 patients were enrolled on the study from July 5, 2013 to July 15, 2019. Of the 153 participants, 64 had newly diagnosed high-risk neuroblastoma. The remaining patients were potential parental donors for the NK infusion during Consolidation. All patients were enrolled at St. Jude Children's Research Hospital.

Participant milestones

Participant milestones
Measure	NB2012 Therapy (Including Induction, Consolidation, and MRD) Plus Antibody (hu14.18K322A) All newly diagnosed high-risk neuroblastoma participants \<19 years of age who had histologic proof of neuroblastoma or positive bone marrow for tumor cells with increased urine catecholamines, with adequate renal and hepatic function, no prior therapy and consent to the study will receive cyclophosphamide and topotecan combined with humanized anti-GD2 antibody (hu14.18K322A).
Overall Study STARTED	64
Overall Study COMPLETED	54
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Reasons for withdrawal
Measure	NB2012 Therapy (Including Induction, Consolidation, and MRD) Plus Antibody (hu14.18K322A) All newly diagnosed high-risk neuroblastoma participants \<19 years of age who had histologic proof of neuroblastoma or positive bone marrow for tumor cells with increased urine catecholamines, with adequate renal and hepatic function, no prior therapy and consent to the study will receive cyclophosphamide and topotecan combined with humanized anti-GD2 antibody (hu14.18K322A).
Overall Study Relapse or progression	2
Overall Study Unacceptable toxicity	3
Overall Study Unwillingness or inability to comply	2
Overall Study Physician Decision	3

Baseline Characteristics

Therapy for Children With Advanced Stage Neuroblastoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	NB2012 Therapy (Including Induction, Consolidation, and MRD) Plus Antibody (hu14.18K322A) n=64 Participants All newly diagnosed, high-risk neuroblastoma participants \<19 years of age who had histologic proof of neuroblastoma or positive bone marrow for tumor cells with increased urine catecholamines, with adequate renal and hepatic function, no prior therapy and consent to the study will receive Induction, Consolidation and MRD treatment with humanized anti-GD2 antibody (hu14.18K322A) included during Induction and Consolidation. A subset of patients also received hu14.18K322A during Consolidation.
Age, Continuous	49.03 months STANDARD_DEVIATION 39.24 • n=202 Participants
Sex: Female, Male Female	27 Participants n=202 Participants
Sex: Female, Male Male	37 Participants n=202 Participants
Race/Ethnicity, Customized White	43 Participants n=202 Participants
Race/Ethnicity, Customized Black	18 Participants n=202 Participants
Race/Ethnicity, Customized Other	3 Participants n=202 Participants
Cyclophosphamide and topotecan combined with humanized anti-GD2 antibody (hu14.18K322A)	64 Participants n=202 Participants

PRIMARY outcome

Timeframe: After two initial courses of chemotherapy (approximately 6 weeks after enrollment)

Outcome measures

Outcome measures
Measure	NB2012 Therapy (Including Induction, Consolidation, and MRD) Antibody (hu14.18K322A) n=63 Participants All newly diagnosed, high-risk neuroblastoma participants \<19 years of age who had histologic proof of neuroblastoma or positive bone marrow for tumor cells with increased urine catecholamines, with adequate renal and hepatic function, no prior therapy and consent to the study.
Overall Response Rate [Complete Response + Very Good Partial Response + Partial Response (CR + VGPR + PR)]	42 Participants

PRIMARY outcome

Timeframe: 3 years, from time of enrollment

EFS was estimated as time to relapse, progressive disease, secondary neoplasm, or death from any cause from enrollment. The EFS was estimated by Kaplan-Meier method

Outcome measures

Outcome measures
Measure	NB2012 Therapy (Including Induction, Consolidation, and MRD) Antibody (hu14.18K322A) n=64 Participants All newly diagnosed, high-risk neuroblastoma participants \<19 years of age who had histologic proof of neuroblastoma or positive bone marrow for tumor cells with increased urine catecholamines, with adequate renal and hepatic function, no prior therapy and consent to the study.
Event-free Survival (EFS)	73.7 percent of probability Interval 60.0 to 83.4

SECONDARY outcome

Timeframe: After 6 cycles of induction therapy (approximately 24 weeks after enrollment)

The study is designed to monitor the feasibility of delivering hu14.18K332A to 6 cycles of Induction chemotherapy. The feasibility of Induction therapy for this study will be to target no worse than 75%. A patient was considered as a "failure" for the 6 cycles of Induction therapy if the patient failed to complete Induction therapy within 155 days since treatment initiation due to toxicity or disease progression, unless the delay was a result of non-medical issues (e.g. not due to protocol toxicity). The proportion of patients who successfully received hu14.18K322A with 6 cycles of induction chemotherapy was estimated together with a 95% confidence interval. The response rate (CR + VGPR + PR) to 6 cycles of Induction chemoimmunotherapy was estimated together with the 95% confidence intervals

Outcome measures

Outcome measures
Measure	NB2012 Therapy (Including Induction, Consolidation, and MRD) Antibody (hu14.18K322A) n=64 Participants All newly diagnosed, high-risk neuroblastoma participants \<19 years of age who had histologic proof of neuroblastoma or positive bone marrow for tumor cells with increased urine catecholamines, with adequate renal and hepatic function, no prior therapy and consent to the study.
Feasibility of Delivering hu14.18K322A to 6 Cycles of Induction Therapy	96.8 percentage of participants Interval 88.8 to 99.6

SECONDARY outcome

Timeframe: Up to 3 years

Local failure is defined as relapse or progression of disease at the primary site. The cumulative incidence of local failure will be estimated; competing events will include distant failure or death prior to local failure.

Outcome measures

Outcome measures
Measure	NB2012 Therapy (Including Induction, Consolidation, and MRD) Antibody (hu14.18K322A) n=64 Participants All newly diagnosed, high-risk neuroblastoma participants \<19 years of age who had histologic proof of neuroblastoma or positive bone marrow for tumor cells with increased urine catecholamines, with adequate renal and hepatic function, no prior therapy and consent to the study.
Local Failure Rate and Pattern of Failure	1.56 percentage of participants Interval 0.13 to 7.46

SECONDARY outcome

Timeframe: During the recovery phase after busulfan/melphalan and PBSC rescue (approximately 24-26 weeks after enrollment)

Number of patients who experience an unacceptable dose limiting toxicity (per CTCAE v 4.0) including the following toxicities: 1) toxicity requiring the use of pressors, including Grade 4 acute capillary leak syndrome or Grade3 and 4 hypotension; 2) Toxicity requiring ventilation support, including Grade 4 respiratory toxicity; 3) Grade 3 or 4 neurotoxicity with MRI evidence of new CNS thrombi, infarction or bleeding in any subject receiving the hu14.18K322A with NK cell combination; 4) Failure of recovery of ANC \> 500/mm3 by day 35 after PBSC infusion. Number of patients who experience Grade 3 or Grade 4 (per Common Toxicity Criteria v 4.0) veno occlusive disease (VOD).

Outcome measures

Outcome measures
Measure	NB2012 Therapy (Including Induction, Consolidation, and MRD) Antibody (hu14.18K322A) n=31 Participants All newly diagnosed, high-risk neuroblastoma participants \<19 years of age who had histologic proof of neuroblastoma or positive bone marrow for tumor cells with increased urine catecholamines, with adequate renal and hepatic function, no prior therapy and consent to the study.
Dose Limiting Toxicity (DLT) or Severe (Grade 3 or 4) VOD With hu14.18K322A With Allogeneic NK Cells in Consolidation	0 Participants

SECONDARY outcome

Timeframe: During MRD treatment cycle (approximately 8-12 months after enrollment)

Number of patients who experience an unacceptable dose limiting toxicity (per CTCAE v 4.0) including the following toxicities: 1) Toxicity requiring the use of pressors, including Grade 4 acute capillary leak syndrome or Grade 3 and 4 hypotension; 2) Toxicity requiring ventilation support, including Grade 4 respiratory toxicity; 3) Grade 3 or 4 neurotoxicity with MRI evidence of new CNS thrombi, infarction or bleeding.

Outcome measures

Outcome measures
Measure	NB2012 Therapy (Including Induction, Consolidation, and MRD) Antibody (hu14.18K322A) n=42 Participants All newly diagnosed, high-risk neuroblastoma participants \<19 years of age who had histologic proof of neuroblastoma or positive bone marrow for tumor cells with increased urine catecholamines, with adequate renal and hepatic function, no prior therapy and consent to the study.
Dose Limiting Toxicity (DLT)	1 Participants

Adverse Events

NB2012 Therapy (Including Induction, Consolidation, and MRD) Plus Antibody (hu14.18K322A)

Serious events: 40 serious events

Other events: 64 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	NB2012 Therapy (Including Induction, Consolidation, and MRD) Plus Antibody (hu14.18K322A) n=64 participants at risk All newly diagnosed, high-risk neuroblastoma participants \<19 years of age who had histologic proof of neuroblastoma or positive bone marrow for tumor cells with increased urine catecholamines, with adequate renal and hepatic function, no prior therapy and consent to the study.
Blood and lymphatic system disorders Anemia	4.7% 3/64 • Number of events 3 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Blood and lymphatic system disorders Febrile neutropenia	7.8% 5/64 • Number of events 5 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Cardiac disorders Asystole	3.1% 2/64 • Number of events 2 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Cardiac disorders Pericardial effusion	1.6% 1/64 • Number of events 1 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Cardiac disorders Pericarditis	1.6% 1/64 • Number of events 1 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Cardiac disorders Sinus tachycardia	1.6% 1/64 • Number of events 1 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Gastrointestinal disorders Abdominal pain	1.6% 1/64 • Number of events 1 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Gastrointestinal disorders Colitis	1.6% 1/64 • Number of events 1 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Gastrointestinal disorders Diarrhea	3.1% 2/64 • Number of events 2 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Gastrointestinal disorders Esophagitis	1.6% 1/64 • Number of events 1 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Gastrointestinal disorders Intra-abdominal hemorrhage	1.6% 1/64 • Number of events 1 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Gastrointestinal disorders Mucositis oral	9.4% 6/64 • Number of events 6 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Gastrointestinal disorders Nausea	1.6% 1/64 • Number of events 1 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Gastrointestinal disorders Typhlitis	1.6% 1/64 • Number of events 1 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Gastrointestinal disorders Upper gastrointestinal hemorrhage	1.6% 1/64 • Number of events 1 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Gastrointestinal disorders Vomiting	6.2% 4/64 • Number of events 4 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
General disorders Fatigue	1.6% 1/64 • Number of events 1 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
General disorders Fever	4.7% 3/64 • Number of events 3 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
General disorders Infusion related reaction	1.6% 1/64 • Number of events 1 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
General disorders Pain	1.6% 1/64 • Number of events 1 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Hepatobiliary disorders Hepatic failure	1.6% 1/64 • Number of events 1 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Hepatobiliary disorders Hepatobiliary disorders - Other, specify	1.6% 1/64 • Number of events 1 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Infections and infestations Catheter related infection	3.1% 2/64 • Number of events 2 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Infections and infestations Duodenal infection	1.6% 1/64 • Number of events 1 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Infections and infestations Enterocolitis infectious	7.8% 5/64 • Number of events 5 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Infections and infestations Infections and infestations - Other, specify	3.1% 2/64 • Number of events 2 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Infections and infestations Sepsis	3.1% 2/64 • Number of events 2 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Infections and infestations Upper respiratory infection	9.4% 6/64 • Number of events 6 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Infections and infestations Urinary tract infection	3.1% 2/64 • Number of events 2 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Investigations Aspartate aminotransferase increased	1.6% 1/64 • Number of events 1 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Investigations Blood bilirubin increased	1.6% 1/64 • Number of events 1 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Investigations GGT increased	4.7% 3/64 • Number of events 3 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Investigations Lymphocyte count decreased	14.1% 9/64 • Number of events 9 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Investigations Neutrophil count decreased	12.5% 8/64 • Number of events 8 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Investigations Platelet count decreased	14.1% 9/64 • Number of events 9 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Investigations White blood cell decreased	7.8% 5/64 • Number of events 5 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Metabolism and nutrition disorders Anorexia	3.1% 2/64 • Number of events 2 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Metabolism and nutrition disorders Dehydration	6.2% 4/64 • Number of events 4 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Investigations Hyperuricemia	1.6% 1/64 • Number of events 1 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Metabolism and nutrition disorders Hypocalcemia	1.6% 1/64 • Number of events 1 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Metabolism and nutrition disorders Hypokalemia	1.6% 1/64 • Number of events 1 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other, specify	1.6% 1/64 • Number of events 1 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Nervous system disorders Depressed level of consciousness	1.6% 1/64 • Number of events 1 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Nervous system disorders Encephalopathy	1.6% 1/64 • Number of events 1 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Renal and urinary disorders Acute kidney injury	1.6% 1/64 • Number of events 1 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Renal and urinary disorders Cystitis noninfective	1.6% 1/64 • Number of events 1 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Respiratory, thoracic and mediastinal disorders Apnea	1.6% 1/64 • Number of events 1 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Respiratory, thoracic and mediastinal disorders Aspiration	1.6% 1/64 • Number of events 1 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Respiratory, thoracic and mediastinal disorders Atelectasis	1.6% 1/64 • Number of events 1 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Respiratory, thoracic and mediastinal disorders Dyspnea	1.6% 1/64 • Number of events 1 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Respiratory, thoracic and mediastinal disorders Hypoxia	4.7% 3/64 • Number of events 3 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Respiratory, thoracic and mediastinal disorders Pneumothorax	1.6% 1/64 • Number of events 1 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Respiratory, thoracic and mediastinal disorders Pulmonary edema	1.6% 1/64 • Number of events 1 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	1.6% 1/64 • Number of events 1 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Respiratory, thoracic and mediastinal disorders Respiratory failure	3.1% 2/64 • Number of events 2 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Vascular disorders Hypertension	3.1% 2/64 • Number of events 2 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Vascular disorders Hypotension	4.7% 3/64 • Number of events 3 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Vascular disorders Thromboembolic event	1.6% 1/64 • Number of events 1 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities

Other adverse events

Other adverse events
Measure	NB2012 Therapy (Including Induction, Consolidation, and MRD) Plus Antibody (hu14.18K322A) n=64 participants at risk All newly diagnosed, high-risk neuroblastoma participants \<19 years of age who had histologic proof of neuroblastoma or positive bone marrow for tumor cells with increased urine catecholamines, with adequate renal and hepatic function, no prior therapy and consent to the study.
Blood and lymphatic system disorders Febrile neutropenia	90.6% 58/64 • Number of events 58 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Blood and lymphatic system disorders Anemia	100.0% 64/64 • Number of events 64 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Ear and labyrinth disorders Hearing impaired	31.2% 20/64 • Number of events 20 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Gastrointestinal disorders Mucositis oral	70.3% 45/64 • Number of events 45 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Gastrointestinal disorders Vomiting	42.2% 27/64 • Number of events 27 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Gastrointestinal disorders Nausea	31.2% 20/64 • Number of events 20 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Gastrointestinal disorders Diarrhea	28.1% 18/64 • Number of events 18 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Gastrointestinal disorders Abdominal pain	25.0% 16/64 • Number of events 16 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Gastrointestinal disorders Esophagitis	12.5% 8/64 • Number of events 8 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Gastrointestinal disorders Colitis	10.9% 7/64 • Number of events 7 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Gastrointestinal disorders Ascites	9.4% 6/64 • Number of events 6 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Gastrointestinal disorders Abdominal distension	6.2% 4/64 • Number of events 4 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Gastrointestinal disorders Small intestinal obstruction	6.2% 4/64 • Number of events 4 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
General disorders Fever	59.4% 38/64 • Number of events 38 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
General disorders Pain	43.8% 28/64 • Number of events 28 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
General disorders Infusion related reaction	23.4% 15/64 • Number of events 15 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
General disorders Fatigue	7.8% 5/64 • Number of events 5 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Hepatobiliary disorders Hepatobiliary disorders - Other, specify	20.3% 13/64 • Number of events 13 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Infections and infestations Enterocolitis infectious	67.2% 43/64 • Number of events 43 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Infections and infestations Upper respiratory infection	64.1% 41/64 • Number of events 41 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Infections and infestations Catheter related infection	50.0% 32/64 • Number of events 32 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Infections and infestations Urinary tract infection	37.5% 24/64 • Number of events 24 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Infections and infestations Device related infection	23.4% 15/64 • Number of events 15 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Infections and infestations Sepsis	20.3% 13/64 • Number of events 13 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Infections and infestations Infections and infestations - Other, specify	12.5% 8/64 • Number of events 8 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Infections and infestations Bladder infection	7.8% 5/64 • Number of events 5 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Infections and infestations Skin infection	7.8% 5/64 • Number of events 5 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Investigations Alanine aminotransferase increased	46.9% 30/64 • Number of events 30 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Investigations Lymphocyte count increased	45.3% 29/64 • Number of events 29 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Investigations Aspartate aminotransferase increased	37.5% 24/64 • Number of events 24 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Investigations Blood bilirubin increased	26.6% 17/64 • Number of events 17 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Investigations GGT increased	25.0% 16/64 • Number of events 16 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Investigations Lymphocyte count decreased	100.0% 64/64 • Number of events 64 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Investigations Neutrophil count decreased	100.0% 64/64 • Number of events 64 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Investigations Platelet count decreased	100.0% 64/64 • Number of events 64 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Investigations White blood cell decreased	100.0% 64/64 • Number of events 64 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Investigations Blood antidiuretic hormone abnormal	6.2% 4/64 • Number of events 4 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Metabolism and nutrition disorders Hypokalemia	78.1% 50/64 • Number of events 50 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Metabolism and nutrition disorders Hypophosphatemia	70.3% 45/64 • Number of events 45 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Metabolism and nutrition disorders Hyperglycemia	51.6% 33/64 • Number of events 33 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Metabolism and nutrition disorders Hyponatremia	51.6% 33/64 • Number of events 33 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Metabolism and nutrition disorders Acidosis	45.3% 29/64 • Number of events 29 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Metabolism and nutrition disorders Hypocalcemia	35.9% 23/64 • Number of events 23 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Metabolism and nutrition disorders Anorexia	26.6% 17/64 • Number of events 17 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Metabolism and nutrition disorders Dehydration	23.4% 15/64 • Number of events 15 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Metabolism and nutrition disorders Hyperkalemia	17.2% 11/64 • Number of events 11 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Metabolism and nutrition disorders Alkalosis	10.9% 7/64 • Number of events 7 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Metabolism and nutrition disorders Hypoglycemia	9.4% 6/64 • Number of events 6 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Metabolism and nutrition disorders Hyperuricemia	7.8% 5/64 • Number of events 5 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Metabolism and nutrition disorders Hypoalbuminemia	7.8% 5/64 • Number of events 5 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Metabolism and nutrition disorders Hypermagnesemia	6.2% 4/64 • Number of events 4 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Musculoskeletal and connective tissue disorders Pain in extremity	6.2% 4/64 • Number of events 4 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Psychiatric disorders Agitation	6.2% 4/64 • Number of events 4 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Renal and urinary disorders Cystitis noninfective	12.5% 8/64 • Number of events 8 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Respiratory, thoracic and mediastinal disorders Hypoxia	48.4% 31/64 • Number of events 31 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Respiratory, thoracic and mediastinal disorders Epistaxis	23.4% 15/64 • Number of events 15 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Respiratory, thoracic and mediastinal disorders Atelectasis	14.1% 9/64 • Number of events 9 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Respiratory, thoracic and mediastinal disorders Cough	12.5% 8/64 • Number of events 8 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Respiratory, thoracic and mediastinal disorders Pleural effusion	12.5% 8/64 • Number of events 8 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Respiratory, thoracic and mediastinal disorders Bronchospasm	7.8% 5/64 • Number of events 5 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Respiratory, thoracic and mediastinal disorders Dyspnea	6.2% 4/64 • Number of events 4 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Skin and subcutaneous tissue disorders Pruritus	6.2% 4/64 • Number of events 4 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Skin and subcutaneous tissue disorders Rash acneiform	6.2% 4/64 • Number of events 4 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Vascular disorders Hypotension	45.3% 29/64 • Number of events 29 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities
Vascular disorders Hypertension	18.8% 12/64 • Number of events 12 • Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment. CTCAE v4.0 Grades 3 and 4 toxicities

Additional Information

Sara M. Federico, MD

St. Jude Children's Research Hospital

Phone: 866-278-5833

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place