Trial Outcomes & Findings for Induction Therapy Including 131 I-MIBG and Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma Undergoing Stem Cell Transplant, Radiation Therapy, and Maintenance Therapy With Isotretinoin (NCT NCT01175356)
NCT ID: NCT01175356
Last Updated: 2026-01-23
Results Overview
Number of MIBG avid patients who receive 131I-MIBG divided by the number of patients evaluable for the feasibility of MIBG endpoint x 100%.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
99 participants
Primary outcome timeframe
Up to 6 weeks after course 5 of induction
Results posted on
2026-01-23
Participant Flow
Participant milestones
| Measure |
Treatment (131I-MIBG, Chemotherapy)
Induction with multi-agent chemotherapy and MIBG labeled with iodine-131/isotretinoin/vincristine followed by Consolidation with BuMel Chemotherapy+ASCT+XRT.
|
|---|---|
|
Overall Study
STARTED
|
99
|
|
Overall Study
COMPLETED
|
18
|
|
Overall Study
NOT COMPLETED
|
81
|
Reasons for withdrawal
| Measure |
Treatment (131I-MIBG, Chemotherapy)
Induction with multi-agent chemotherapy and MIBG labeled with iodine-131/isotretinoin/vincristine followed by Consolidation with BuMel Chemotherapy+ASCT+XRT.
|
|---|---|
|
Overall Study
Death
|
1
|
|
Overall Study
Lack of Efficacy
|
12
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Physician Decision
|
23
|
|
Overall Study
Ineligible
|
1
|
|
Overall Study
Treatment Slot Not Available
|
18
|
|
Overall Study
Refusal by patient/parent/guardian
|
6
|
|
Overall Study
Pts MIBG non-avid after enrollment
|
2
|
|
Overall Study
On other COG study w/tumor tx intent
|
7
|
|
Overall Study
Inadequate stem cell for transplant
|
1
|
|
Overall Study
Initiation other tx prior to completion
|
9
|
Baseline Characteristics
Induction Therapy Including 131 I-MIBG and Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma Undergoing Stem Cell Transplant, Radiation Therapy, and Maintenance Therapy With Isotretinoin
Baseline characteristics by cohort
| Measure |
Treatment (131I-MIBG, Chemotherapy)
n=99 Participants
Induction with multi-agent chemotherapy and MIBG labeled with iodine-131/isotretinoin/vincristine followed by Consolidation with BuMel Chemotherapy+ASCT+XRT.
|
|---|---|
|
Age, Categorical
<=18 years
|
99 Participants
n=270 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=270 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=270 Participants
|
|
Age, Continuous
|
4.2 Years
STANDARD_DEVIATION 2.9 • n=270 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=270 Participants
|
|
Sex: Female, Male
Male
|
60 Participants
n=270 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=270 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
86 Participants
n=270 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=270 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=270 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=270 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=270 Participants
|
|
Race (NIH/OMB)
Black or African American
|
18 Participants
n=270 Participants
|
|
Race (NIH/OMB)
White
|
64 Participants
n=270 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=270 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
13 Participants
n=270 Participants
|
PRIMARY outcome
Timeframe: Up to 6 weeks after course 5 of inductionPopulation: Includes patients who met criteria to receive 131I-MIBG but went off protocol therapy before receiving a dose assignment, but excludes patients that could not continue onto 131I-MIBG therapy due to lack of an open treatment slot. The definition of receiving MIBG labeled with iodine-131 is receiving 131I-MIBG.
Number of MIBG avid patients who receive 131I-MIBG divided by the number of patients evaluable for the feasibility of MIBG endpoint x 100%.
Outcome measures
| Measure |
Treatment (131I-MIBG, Chemotherapy)
n=68 Participants
Induction with multi-agent chemotherapy and MIBG labeled with iodine-131/isotretinoin/vincristine followed by Consolidation with BuMel Chemotherapy+ASCT+XRT.
|
|---|---|
|
Percentage of MIBG Avid Patients Treated With Meta-iodobenxylguanide (MIBG) Labeled With Iodine-131
|
86.8 Percentage of participants
Interval 76.7 to 92.9
|
PRIMARY outcome
Timeframe: Up to day -6 of conditioningPopulation: Includes patients who met criteria to receive 131I-MIBG but went off protocol therapy before receiving a dose assignment, but excludes patients that could not receive 131I-MIBG therapy due to lack of an open treatment slot. The definition of receiving Bu/Mel conditioning is receiving the first dose of planned Busulfan on Day -6 of conditioning.
Number of MIBG avid patients who receive 131I-MIBG and Bu/Mel divided by the number of patients evaluable for the feasibility of MIBG and Bu/Mel consolidation endpoint x 100%.
Outcome measures
| Measure |
Treatment (131I-MIBG, Chemotherapy)
n=45 Participants
Induction with multi-agent chemotherapy and MIBG labeled with iodine-131/isotretinoin/vincristine followed by Consolidation with BuMel Chemotherapy+ASCT+XRT.
|
|---|---|
|
Percentage of MIBG Avid Patients Treated With MIBG Labeled With Iodine-131 and Bu/Mel Chemotherapy
|
82.2 Percentage of participants
Interval 68.7 to 90.7
|
SECONDARY outcome
Timeframe: Up to 6 weeks after course 5 of inductionPopulation: Includes patients who received 131I-MIBG therapy.
Number of patients who had an unacceptable toxicity or experienced SOS. Unacceptable toxicity was defined as CTC Grade 4-5 Pulmonary/Respiratory.
Outcome measures
| Measure |
Treatment (131I-MIBG, Chemotherapy)
n=53 Participants
Induction with multi-agent chemotherapy and MIBG labeled with iodine-131/isotretinoin/vincristine followed by Consolidation with BuMel Chemotherapy+ASCT+XRT.
|
|---|---|
|
Incidence of Unacceptable Toxicity and Sinusoidal Obstruction Syndrome (SOS), Assessed by Common Terminology Criteria (CTV)v.4.0 for Toxicity Assessment and Grading for I-MIBG
|
3 Participants
|
Adverse Events
Treatment (131I-MIBG, Chemotherapy)
Serious events: 27 serious events
Other events: 86 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (131I-MIBG, Chemotherapy)
n=98 participants at risk
Induction with multi-agent chemotherapy and MIBG labeled with iodine-131/isotretinoin/vincristine followed by Consolidation with BuMel Chemotherapy+ASCT+XRT.
|
|---|---|
|
Cardiac disorders
39000-Heart failure
|
1.0%
1/98 • Number of events 1
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Cardiac disorders
74500-Sinus tachycardia
|
1.0%
1/98 • Number of events 1
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Gastrointestinal disorders
10300-Abdominal pain
|
1.0%
1/98 • Number of events 1
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Gastrointestinal disorders
14900-Ascites
|
6.1%
6/98 • Number of events 6
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Gastrointestinal disorders
55600-Mucositis oral
|
2.0%
2/98 • Number of events 2
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
General disorders
24600-Death NOS
|
13.3%
13/98 • Number of events 13
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
General disorders
37200-General disorders and administration site conditions - Other specify
|
1.0%
1/98 • Number of events 1
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
General disorders
55700-Multi-organ failure
|
2.0%
2/98 • Number of events 2
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
General disorders
60600-Pain
|
1.0%
1/98 • Number of events 1
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Hepatobiliary disorders
21600-Cholecystitis
|
1.0%
1/98 • Number of events 1
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Hepatobiliary disorders
40000-Hepatic failure
|
2.0%
2/98 • Number of events 2
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Hepatobiliary disorders
40400-Hepatic pain
|
2.0%
2/98 • Number of events 2
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Hepatobiliary disorders
40600-Hepatobiliary disorders - Other specify
|
2.0%
2/98 • Number of events 2
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Hepatobiliary disorders
66500-Portal hypertension
|
3.1%
3/98 • Number of events 3
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Infections and infestations
44800-Infections and infestations - Other specify
|
2.0%
2/98 • Number of events 2
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Infections and infestations
53100-Lung infection
|
1.0%
1/98 • Number of events 1
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Infections and infestations
73700-Sepsis
|
3.1%
3/98 • Number of events 3
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Investigations
10900-Activated partial thromboplastin time prolonged
|
2.0%
2/98 • Number of events 2
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Investigations
11600-Alanine aminotransferase increased
|
4.1%
4/98 • Number of events 4
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Investigations
15000-Aspartate aminotransferase increased
|
4.1%
4/98 • Number of events 4
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Investigations
17400-Blood bilirubin increased
|
8.2%
8/98 • Number of events 8
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Investigations
45800-INR increased
|
2.0%
2/98 • Number of events 2
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Investigations
88200-Weight gain
|
5.1%
5/98 • Number of events 5
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Investigations
88300-Weight loss
|
2.0%
2/98 • Number of events 2
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Metabolism and nutrition disorders
10700-Acidosis
|
1.0%
1/98 • Number of events 1
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Metabolism and nutrition disorders
13500-Anorexia
|
1.0%
1/98 • Number of events 1
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Metabolism and nutrition disorders
41600-Hyperkalemia
|
1.0%
1/98 • Number of events 1
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Metabolism and nutrition disorders
41800-Hypernatremia
|
1.0%
1/98 • Number of events 1
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Metabolism and nutrition disorders
42600-Hypoalbuminemia
|
2.0%
2/98 • Number of events 2
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Metabolism and nutrition disorders
43100-Hypokalemia
|
2.0%
2/98 • Number of events 3
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Metabolism and nutrition disorders
43300-Hyponatremia
|
3.1%
3/98 • Number of events 3
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
58000-Neoplasms benign malignant and unspecified (incl cysts and polyps) - Other specify
|
1.0%
1/98 • Number of events 1
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Nervous system disorders
72500-Reversible posterior leukoencephalopathy syndrome
|
1.0%
1/98 • Number of events 1
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Respiratory, thoracic and mediastinal disorders
43900-Hypoxia
|
5.1%
5/98 • Number of events 5
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Respiratory, thoracic and mediastinal disorders
65900-Pleural effusion
|
3.1%
3/98 • Number of events 3
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Respiratory, thoracic and mediastinal disorders
69000-Pulmonary hypertension
|
1.0%
1/98 • Number of events 1
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Respiratory, thoracic and mediastinal disorders
71600-Respiratory thoracic and mediastinal disorders - Other specify
|
1.0%
1/98 • Number of events 1
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Vascular disorders
43600-Hypotension
|
1.0%
1/98 • Number of events 1
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
Other adverse events
| Measure |
Treatment (131I-MIBG, Chemotherapy)
n=98 participants at risk
Induction with multi-agent chemotherapy and MIBG labeled with iodine-131/isotretinoin/vincristine followed by Consolidation with BuMel Chemotherapy+ASCT+XRT.
|
|---|---|
|
General disorders
33900-Fever
|
1.0%
1/98 • Number of events 1
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
General disorders
37200-General disorders and administration site conditions - Other specify
|
1.0%
1/98 • Number of events 1
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Blood and lymphatic system disorders
13200-Anemia
|
24.5%
24/98 • Number of events 49
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Blood and lymphatic system disorders
33300-Febrile neutropenia
|
55.1%
54/98 • Number of events 81
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Cardiac disorders
20000-Cardiac arrest
|
1.0%
1/98 • Number of events 1
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Cardiac disorders
78900-Supraventricular tachycardia
|
1.0%
1/98 • Number of events 1
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Ear and labyrinth disorders
38900-Hearing impaired
|
9.2%
9/98 • Number of events 11
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Gastrointestinal disorders
10100-Abdominal distension
|
1.0%
1/98 • Number of events 1
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Gastrointestinal disorders
10300-Abdominal pain
|
7.1%
7/98 • Number of events 7
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Gastrointestinal disorders
14900-Ascites
|
5.1%
5/98 • Number of events 5
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Gastrointestinal disorders
22100-Colitis
|
1.0%
1/98 • Number of events 1
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Gastrointestinal disorders
25700-Diarrhea
|
6.1%
6/98 • Number of events 7
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Gastrointestinal disorders
29400-Enterocolitis
|
1.0%
1/98 • Number of events 1
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Gastrointestinal disorders
36400-Gastritis
|
1.0%
1/98 • Number of events 1
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Gastrointestinal disorders
44600-Ileus
|
1.0%
1/98 • Number of events 1
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Gastrointestinal disorders
55600-Mucositis oral
|
19.4%
19/98 • Number of events 22
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Gastrointestinal disorders
57600-Nausea
|
15.3%
15/98 • Number of events 17
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Gastrointestinal disorders
59700-Oral pain
|
2.0%
2/98 • Number of events 2
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Gastrointestinal disorders
81900-Typhlitis
|
1.0%
1/98 • Number of events 1
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Gastrointestinal disorders
87900-Vomiting
|
18.4%
18/98 • Number of events 20
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
General disorders
60600-Pain
|
7.1%
7/98 • Number of events 8
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Immune system disorders
12000-Allergic reaction
|
1.0%
1/98 • Number of events 1
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Immune system disorders
13100-Anaphylaxis
|
1.0%
1/98 • Number of events 1
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Infections and infestations
20500-Catheter related infection
|
10.2%
10/98 • Number of events 11
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Infections and infestations
25600-Device related infection
|
1.0%
1/98 • Number of events 1
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Infections and infestations
44800-Infections and infestations - Other specify
|
17.3%
17/98 • Number of events 18
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Infections and infestations
53100-Lung infection
|
2.0%
2/98 • Number of events 2
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Infections and infestations
61100-Pancreas infection
|
1.0%
1/98 • Number of events 1
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Infections and infestations
73700-Sepsis
|
4.1%
4/98 • Number of events 4
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Infections and infestations
74600-Sinusitis
|
1.0%
1/98 • Number of events 1
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Infections and infestations
75200-Skin infection
|
1.0%
1/98 • Number of events 1
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Infections and infestations
76000-Small intestine infection
|
1.0%
1/98 • Number of events 1
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Infections and infestations
82300-Upper respiratory infection
|
1.0%
1/98 • Number of events 1
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Infections and infestations
83100-Urinary tract infection
|
4.1%
4/98 • Number of events 4
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Infections and infestations
88900-Wound infection
|
2.0%
2/98 • Number of events 2
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Injury, poisoning and procedural complications
13800-Aortic injury
|
1.0%
1/98 • Number of events 1
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Injury, poisoning and procedural complications
45700-Injury poisoning and procedural complications - Other specify
|
1.0%
1/98 • Number of events 1
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Injury, poisoning and procedural complications
47300-Intraoperative hepatobiliary injury
|
1.0%
1/98 • Number of events 1
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Injury, poisoning and procedural complications
47700-Intraoperative renal injury
|
1.0%
1/98 • Number of events 1
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Investigations
10900-Activated partial thromboplastin time prolonged
|
1.0%
1/98 • Number of events 1
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Investigations
11600-Alanine aminotransferase increased
|
14.3%
14/98 • Number of events 15
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Investigations
15000-Aspartate aminotransferase increased
|
14.3%
14/98 • Number of events 14
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Investigations
17400-Blood bilirubin increased
|
1.0%
1/98 • Number of events 1
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Investigations
24100-Creatinine increased
|
2.0%
2/98 • Number of events 2
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Investigations
34000-Fibrinogen decreased
|
1.0%
1/98 • Number of events 1
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Investigations
37500-GGT increased
|
1.0%
1/98 • Number of events 1
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Investigations
52600-Lipase increased
|
1.0%
1/98 • Number of events 1
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Investigations
53700-Lymphocyte count decreased
|
21.4%
21/98 • Number of events 49
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Investigations
58300-Neutrophil count decreased
|
27.6%
27/98 • Number of events 56
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Investigations
65800-Platelet count decreased
|
28.6%
28/98 • Number of events 59
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Investigations
88200-Weight gain
|
1.0%
1/98 • Number of events 1
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Investigations
88300-Weight loss
|
1.0%
1/98 • Number of events 1
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Investigations
88500-White blood cell decreased
|
23.5%
23/98 • Number of events 50
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Metabolism and nutrition disorders
10700-Acidosis
|
1.0%
1/98 • Number of events 1
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Metabolism and nutrition disorders
13500-Anorexia
|
33.7%
33/98 • Number of events 48
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Metabolism and nutrition disorders
24700-Dehydration
|
12.2%
12/98 • Number of events 12
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Metabolism and nutrition disorders
41300-Hypercalcemia
|
1.0%
1/98 • Number of events 1
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Metabolism and nutrition disorders
41400-Hyperglycemia
|
9.2%
9/98 • Number of events 12
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Metabolism and nutrition disorders
41600-Hyperkalemia
|
2.0%
2/98 • Number of events 2
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Metabolism and nutrition disorders
41700-Hypermagnesemia
|
1.0%
1/98 • Number of events 1
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Metabolism and nutrition disorders
41800-Hypernatremia
|
1.0%
1/98 • Number of events 1
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Metabolism and nutrition disorders
42600-Hypoalbuminemia
|
3.1%
3/98 • Number of events 3
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Metabolism and nutrition disorders
42700-Hypocalcemia
|
3.1%
3/98 • Number of events 3
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Metabolism and nutrition disorders
42900-Hypoglycemia
|
1.0%
1/98 • Number of events 1
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Metabolism and nutrition disorders
43100-Hypokalemia
|
33.7%
33/98 • Number of events 36
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Metabolism and nutrition disorders
43200-Hypomagnesemia
|
2.0%
2/98 • Number of events 2
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Metabolism and nutrition disorders
43300-Hyponatremia
|
8.2%
8/98 • Number of events 9
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Metabolism and nutrition disorders
43500-Hypophosphatemia
|
16.3%
16/98 • Number of events 18
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Metabolism and nutrition disorders
54900-Metabolism and nutrition disorders - Other specify
|
2.0%
2/98 • Number of events 2
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Musculoskeletal and connective tissue disorders
18200-Bone pain
|
1.0%
1/98 • Number of events 1
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Musculoskeletal and connective tissue disorders
37300-Generalized muscle weakness
|
1.0%
1/98 • Number of events 1
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Musculoskeletal and connective tissue disorders
60700-Pain in extremity
|
2.0%
2/98 • Number of events 2
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Nervous system disorders
10500-Abducens nerve disorder
|
1.0%
1/98 • Number of events 1
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Nervous system disorders
38800-Headache
|
2.0%
2/98 • Number of events 2
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Nervous system disorders
79100-Syncope
|
1.0%
1/98 • Number of events 1
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Psychiatric disorders
11400-Agitation
|
2.0%
2/98 • Number of events 2
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Psychiatric disorders
13700-Anxiety
|
1.0%
1/98 • Number of events 1
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Psychiatric disorders
25400-Depression
|
1.0%
1/98 • Number of events 1
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Renal and urinary disorders
11100-Acute kidney injury
|
1.0%
1/98 • Number of events 1
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Renal and urinary disorders
39300-Hematuria
|
2.0%
2/98 • Number of events 2
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Renal and urinary disorders
71100-Renal calculi
|
1.0%
1/98 • Number of events 1
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Respiratory, thoracic and mediastinal disorders
19300-Bronchospasm
|
1.0%
1/98 • Number of events 1
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Respiratory, thoracic and mediastinal disorders
29700-Epistaxis
|
3.1%
3/98 • Number of events 4
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Respiratory, thoracic and mediastinal disorders
43900-Hypoxia
|
8.2%
8/98 • Number of events 8
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Respiratory, thoracic and mediastinal disorders
64900-Pharyngeal mucositis
|
1.0%
1/98 • Number of events 1
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Respiratory, thoracic and mediastinal disorders
66400-Pneumothorax
|
1.0%
1/98 • Number of events 1
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Respiratory, thoracic and mediastinal disorders
68700-Pulmonary edema
|
2.0%
2/98 • Number of events 2
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Respiratory, thoracic and mediastinal disorders
69000-Pulmonary hypertension
|
1.0%
1/98 • Number of events 1
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Respiratory, thoracic and mediastinal disorders
71500-Respiratory failure
|
2.0%
2/98 • Number of events 2
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Respiratory, thoracic and mediastinal disorders
78100-Stridor
|
1.0%
1/98 • Number of events 2
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Skin and subcutaneous tissue disorders
74700-Skin and subcutaneous tissue disorders - Other specify
|
1.0%
1/98 • Number of events 1
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Surgical and medical procedures
79000-Surgical and medical procedures - Other specify
|
1.0%
1/98 • Number of events 1
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Vascular disorders
39100-Hematoma
|
1.0%
1/98 • Number of events 1
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Vascular disorders
42100-Hypertension
|
1.0%
1/98 • Number of events 2
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
|
Vascular disorders
43600-Hypotension
|
4.1%
4/98 • Number of events 4
The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
|
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 approval.
- Publication restrictions are in place
Restriction type: OTHER