Trial Outcomes & Findings for Busulfan, Melphalan, and Stem Cell Transplant After Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma (NCT NCT01798004)

Last Updated: 2024-07-15

Results Overview

Number of patients who experience one or more unacceptable toxicities (severe sinusoidal obstruction syndrome \[SOS\] or Grade 4-5 pulmonary toxicity per Common Toxicity Criteria \[CTC\] v.4.0) during the Consolidation phase of therapy.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

150 participants

Primary outcome timeframe

Up to 28 days post-consolidation therapy, up to 1 year

Results posted on

2024-07-15

Participant Flow

Participant milestones

Participant milestones
Measure	All Patients Induction with multi-agent chemotherapy followed by Consolidation with BuMel chemotherapy + ASCT + XRT
Overall Study STARTED	150
Overall Study COMPLETED	63
Overall Study NOT COMPLETED	87

Reasons for withdrawal

Reasons for withdrawal
Measure	All Patients Induction with multi-agent chemotherapy followed by Consolidation with BuMel chemotherapy + ASCT + XRT
Overall Study Death	2
Overall Study Lack of Efficacy	8
Overall Study Physician Decision	25
Overall Study Withdrawal by Subject	4
Overall Study Ineligible	4
Overall Study Patient/parent refusal	7
Overall Study Initiation of other non-protocol therapy	5
Overall Study Enrollment another COG therapeutic trial	32

Baseline Characteristics

Busulfan, Melphalan, and Stem Cell Transplant After Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Patients n=150 Participants Induction with multi-agent chemotherapy followed by Consolidation with BuMel chemotherapy + ASCT + XRT
Age, Categorical <=18 years	149 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	3.1 Years n=5 Participants
Sex: Female, Male Female	60 Participants n=5 Participants
Sex: Female, Male Male	90 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	129 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	11 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	21 Participants n=5 Participants
Race (NIH/OMB) White	107 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	11 Participants n=5 Participants
Region of Enrollment New Zealand	1 participants n=5 Participants
Region of Enrollment Canada	14 participants n=5 Participants
Region of Enrollment United States	132 participants n=5 Participants
Region of Enrollment Australia	3 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 28 days post-consolidation therapy, up to 1 year

Population: All eligible and evaluable patients who received at least one dose of either busulfan or melphalan.

Outcome measures

Outcome measures
Measure	All Patients n=101 Participants Induction with multi-agent chemotherapy followed by Consolidation with BuMel Chemotherapy+ASCT+XRT
The Tolerability of BuMel Regimen	9 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 180 days

Assessed by a descriptive analysis of the incidence of grade 3-5 non-hematologic toxicities (CTC v4.0) and all-cause mortality during consolidation therapy. In addition, a descriptive analysis of "late" onset grade 4-5 pulmonary and hepatic complications that occur within 180 days of the start of consolidation therapy will be examined, regardless if the patient has proceeded to other therapy (including chimeric antibody) during that 180 day period.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 5 years

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 5 years

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 5 years

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Within 28 days following consolidation

Relationship with occurrence of non-hematologic toxicities assessed by a descriptive analysis. Association between busulfan exposure levels as measured by the area under the curve (AUC) and event-free survival and overall survival will be examined using Cox proportional hazards models.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to week 12 (course 4 of induction therapy)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to week 12 (course 4 of induction therapy)

Cohen's kappa will be calculated to evaluate the concordance in Curie scores between each of the scoring methods at each time point. Up to 160 MIBG scans are expected at diagnosis and up to 144 MIBG scans from the 90% of patients estimated to be MIBG avid are projected post-course 4 of induction therapy, for a total of up to 304 MIBG scans.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Within 6 weeks of diagnosis

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Within 8 weeks of diagnosis

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Within 28 days post-consolidation

A descriptive analysis of the relationship between melphalan pharmacokinetics and the combination of busulfan and melphalan AUC with the occurrence of non-hematologic toxicities within 28 days following completion of consolidation will be assessed. In addition, the association between melphalan exposure levels as measured by the AUC and event-free survival and overall survival will be examined using Cox proportional hazards models.

Outcome measures

Outcome data not reported

Adverse Events

All Patients

Serious events: 10 serious events

Other events: 82 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	All Patients n=146 participants at risk Induction with multi-agent chemotherapy followed by Consolidation with BuMel chemotherapy + ASCT + XRT
Gastrointestinal disorders Ascites	0.68% 1/146 • Number of events 1 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
General disorders Death NOS	1.4% 2/146 • Number of events 2 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
General disorders Multi-organ failure	0.68% 1/146 • Number of events 1 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
Hepatobiliary disorders Hepatobiliary disorders - Other, specify	0.68% 1/146 • Number of events 1 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
Infections and infestations Lung infection	1.4% 2/146 • Number of events 2 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
Infections and infestations Sepsis	0.68% 1/146 • Number of events 1 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
Infections and infestations Upper respiratory infection	0.68% 1/146 • Number of events 1 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
Investigations Aspartate aminotransferase increased	0.68% 1/146 • Number of events 1 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
Investigations Blood bilirubin increased	0.68% 1/146 • Number of events 1 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	1.4% 2/146 • Number of events 2 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.68% 1/146 • Number of events 1 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
Respiratory, thoracic and mediastinal disorders Bronchopulmonary hemorrhage	0.68% 1/146 • Number of events 1 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
Respiratory, thoracic and mediastinal disorders Dyspnea	1.4% 2/146 • Number of events 2 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
Respiratory, thoracic and mediastinal disorders Hypoxia	1.4% 2/146 • Number of events 2 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.68% 1/146 • Number of events 1 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
Respiratory, thoracic and mediastinal disorders Pulmonary edema	0.68% 1/146 • Number of events 1 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.4% 2/146 • Number of events 2 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.

Other adverse events

Other adverse events
Measure	All Patients n=146 participants at risk Induction with multi-agent chemotherapy followed by Consolidation with BuMel chemotherapy + ASCT + XRT
Blood and lymphatic system disorders Anemia	0.68% 1/146 • Number of events 1 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
Blood and lymphatic system disorders Febrile neutropenia	20.5% 30/146 • Number of events 33 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
Cardiac disorders Asystole	0.68% 1/146 • Number of events 1 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
Cardiac disorders Cardiac arrest	0.68% 1/146 • Number of events 1 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
Cardiac disorders Sinus bradycardia	0.68% 1/146 • Number of events 1 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
Cardiac disorders Sinus tachycardia	1.4% 2/146 • Number of events 2 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
Ear and labyrinth disorders Hearing impaired	3.4% 5/146 • Number of events 6 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
Gastrointestinal disorders Abdominal distension	1.4% 2/146 • Number of events 2 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
Gastrointestinal disorders Abdominal pain	2.1% 3/146 • Number of events 3 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
Gastrointestinal disorders Anal pain	0.68% 1/146 • Number of events 1 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
Gastrointestinal disorders Ascites	2.7% 4/146 • Number of events 5 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
Gastrointestinal disorders Colitis	0.68% 1/146 • Number of events 1 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
Gastrointestinal disorders Diarrhea	3.4% 5/146 • Number of events 5 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
Gastrointestinal disorders Enterocolitis	1.4% 2/146 • Number of events 2 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	1.4% 2/146 • Number of events 2 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
Gastrointestinal disorders Lower gastrointestinal hemorrhage	0.68% 1/146 • Number of events 2 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
Gastrointestinal disorders Mucositis oral	31.5% 46/146 • Number of events 46 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
Gastrointestinal disorders Nausea	5.5% 8/146 • Number of events 9 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
Gastrointestinal disorders Vomiting	4.8% 7/146 • Number of events 7 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
General disorders Fever	1.4% 2/146 • Number of events 2 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
General disorders Multi-organ failure	0.68% 1/146 • Number of events 1 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
General disorders Pain	2.7% 4/146 • Number of events 4 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
Hepatobiliary disorders Hepatic pain	0.68% 1/146 • Number of events 2 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
Hepatobiliary disorders Hepatobiliary disorders - Other, specify	0.68% 1/146 • Number of events 1 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
Hepatobiliary disorders Portal hypertension	1.4% 2/146 • Number of events 2 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
Immune system disorders Anaphylaxis	0.68% 1/146 • Number of events 1 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
Immune system disorders Autoimmune disorder	0.68% 1/146 • Number of events 1 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
Infections and infestations Catheter related infection	2.7% 4/146 • Number of events 6 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
Infections and infestations Infections and infestations - Other, specify	7.5% 11/146 • Number of events 13 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
Infections and infestations Lung infection	0.68% 1/146 • Number of events 1 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
Infections and infestations Peritoneal infection	0.68% 1/146 • Number of events 1 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
Infections and infestations Sepsis	2.7% 4/146 • Number of events 5 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
Infections and infestations Tracheitis	0.68% 1/146 • Number of events 1 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
Injury, poisoning and procedural complications Intraoperative arterial injury	0.68% 1/146 • Number of events 1 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
Injury, poisoning and procedural complications Intraoperative hemorrhage	2.7% 4/146 • Number of events 4 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
Injury, poisoning and procedural complications Intraoperative venous injury	0.68% 1/146 • Number of events 1 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
Investigations Alanine aminotransferase increased	4.8% 7/146 • Number of events 8 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
Investigations Aspartate aminotransferase increased	6.2% 9/146 • Number of events 10 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
Investigations Blood bilirubin increased	8.9% 13/146 • Number of events 15 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
Investigations Electrocardiogram QT corrected interval prolonged	0.68% 1/146 • Number of events 1 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
Investigations GGT increased	0.68% 1/146 • Number of events 1 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
Investigations Investigations - Other, specify	0.68% 1/146 • Number of events 1 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
Investigations Neutrophil count decreased	2.7% 4/146 • Number of events 5 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
Investigations Platelet count decreased	1.4% 2/146 • Number of events 2 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
Investigations Weight gain	4.1% 6/146 • Number of events 7 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
Investigations White blood cell decreased	1.4% 2/146 • Number of events 2 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
Metabolism and nutrition disorders Acidosis	0.68% 1/146 • Number of events 1 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
Metabolism and nutrition disorders Anorexia	19.2% 28/146 • Number of events 34 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
Metabolism and nutrition disorders Dehydration	0.68% 1/146 • Number of events 1 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
Metabolism and nutrition disorders Hyperglycemia	5.5% 8/146 • Number of events 8 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
Metabolism and nutrition disorders Hyperkalemia	1.4% 2/146 • Number of events 2 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
Metabolism and nutrition disorders Hypertriglyceridemia	0.68% 1/146 • Number of events 1 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
Metabolism and nutrition disorders Hypoalbuminemia	0.68% 1/146 • Number of events 1 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
Metabolism and nutrition disorders Hypocalcemia	3.4% 5/146 • Number of events 5 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
Metabolism and nutrition disorders Hypoglycemia	0.68% 1/146 • Number of events 1 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
Metabolism and nutrition disorders Hypokalemia	18.5% 27/146 • Number of events 35 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
Metabolism and nutrition disorders Hyponatremia	3.4% 5/146 • Number of events 5 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
Metabolism and nutrition disorders Hypophosphatemia	3.4% 5/146 • Number of events 5 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
Nervous system disorders Seizure	0.68% 1/146 • Number of events 1 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
Nervous system disorders Vasovagal reaction	0.68% 1/146 • Number of events 1 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
Psychiatric disorders Anxiety	0.68% 1/146 • Number of events 1 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
Renal and urinary disorders Acute kidney injury	0.68% 1/146 • Number of events 1 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
Respiratory, thoracic and mediastinal disorders Adult respiratory distress syndrome	0.68% 1/146 • Number of events 1 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
Respiratory, thoracic and mediastinal disorders Apnea	0.68% 1/146 • Number of events 1 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.68% 1/146 • Number of events 1 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
Respiratory, thoracic and mediastinal disorders Epistaxis	2.1% 3/146 • Number of events 3 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
Respiratory, thoracic and mediastinal disorders Hypoxia	4.8% 7/146 • Number of events 8 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
Respiratory, thoracic and mediastinal disorders Pleural effusion	1.4% 2/146 • Number of events 3 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
Respiratory, thoracic and mediastinal disorders Pneumothorax	1.4% 2/146 • Number of events 2 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
Respiratory, thoracic and mediastinal disorders Pulmonary edema	0.68% 1/146 • Number of events 1 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
Respiratory, thoracic and mediastinal disorders Respiratory failure	2.1% 3/146 • Number of events 3 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify	0.68% 1/146 • Number of events 1 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
Respiratory, thoracic and mediastinal disorders Sore throat	0.68% 1/146 • Number of events 1 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
Vascular disorders Capillary leak syndrome	0.68% 1/146 • Number of events 1 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
Vascular disorders Hypertension	1.4% 2/146 • Number of events 2 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
Vascular disorders Hypotension	2.1% 3/146 • Number of events 4 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
Vascular disorders Thromboembolic event	0.68% 1/146 • Number of events 1 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
Vascular disorders Vascular disorders - Other, specify	0.68% 1/146 • Number of events 1 • Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for 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