Trial Outcomes & Findings for Cyclophosphamide and Prednisone With or Without Immunoglobulin in Treating Abnormal Muscle Movement in Children With Neuroblastoma (NCT NCT00033293)
NCT ID: NCT00033293
Last Updated: 2023-04-18
Results Overview
A multi-stage design followed by a test of proportions between the treatment arms (chemo vs. chemo + therapeutic immune globulin (IVIG)) will be performed. The first stage of the multi-stage design will also function as an early stopping rule for insufficient activity of chemotherapy in OMA.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
53 participants
Primary outcome timeframe
Changes from baseline to 2 months, 6 months, and 1 year
Results posted on
2023-04-18
Participant Flow
Participant milestones
| Measure |
Arm I (Chemotherapy, Immunoglobulin Therapy)
Patients with intermediate-risk or high-risk neuroblastoma receive chemotherapy (including cyclophosphamide) according to the standard of care for the stage of primary neuroblastoma, beginning day 0. Patients with low-risk neuroblastoma (and not receiving other chemotherapy) receive cyclophosphamide IV over 1 hr on day 0. Treatment repeats every 4 wks for 6 courses in the absence of disease progression or unacceptable toxicity. All patients receive oral prednisone twice daily for 3 mths and then every other day for 7-15 mths.
Patients receive therapeutic immune globulin IV on days -2 and -1, at wks 4, 8, 12, 16, 20, and 24, and then at mths 8, 10, and 12 after therapy. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients with no response after 6 months go off treatment. In case of progression of opsoclonus-myoclonus-ataxia (OMA) during evaluation, patient will be switched to another steroid, corticotropin-releasing hormone (ACTH).
|
Arm II (Chemotherapy, Observation)
Patients with intermediate-risk or high-risk neuroblastoma receive chemotherapy (including cyclophosphamide) according to the standard of care for the stage of primary neuroblastoma, beginning on day 0. Patients with low-risk neuroblastoma (and not receiving other chemotherapy) receive cyclophosphamide IV over 1 hour on day 0. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. All patients receive oral prednisone twice daily for 3 months and then every other day for 7-15 months.
Patients do not receive therapeutic immune globulin. Patients with unresponsive opsoclonus-myoclonus-ataxia syndrome after 2 months or progression after 6 months may cross over to arm I.
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
27
|
|
Overall Study
COMPLETED
|
16
|
9
|
|
Overall Study
NOT COMPLETED
|
10
|
18
|
Reasons for withdrawal
| Measure |
Arm I (Chemotherapy, Immunoglobulin Therapy)
Patients with intermediate-risk or high-risk neuroblastoma receive chemotherapy (including cyclophosphamide) according to the standard of care for the stage of primary neuroblastoma, beginning day 0. Patients with low-risk neuroblastoma (and not receiving other chemotherapy) receive cyclophosphamide IV over 1 hr on day 0. Treatment repeats every 4 wks for 6 courses in the absence of disease progression or unacceptable toxicity. All patients receive oral prednisone twice daily for 3 mths and then every other day for 7-15 mths.
Patients receive therapeutic immune globulin IV on days -2 and -1, at wks 4, 8, 12, 16, 20, and 24, and then at mths 8, 10, and 12 after therapy. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients with no response after 6 months go off treatment. In case of progression of opsoclonus-myoclonus-ataxia (OMA) during evaluation, patient will be switched to another steroid, corticotropin-releasing hormone (ACTH).
|
Arm II (Chemotherapy, Observation)
Patients with intermediate-risk or high-risk neuroblastoma receive chemotherapy (including cyclophosphamide) according to the standard of care for the stage of primary neuroblastoma, beginning on day 0. Patients with low-risk neuroblastoma (and not receiving other chemotherapy) receive cyclophosphamide IV over 1 hour on day 0. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. All patients receive oral prednisone twice daily for 3 months and then every other day for 7-15 months.
Patients do not receive therapeutic immune globulin. Patients with unresponsive opsoclonus-myoclonus-ataxia syndrome after 2 months or progression after 6 months may cross over to arm I.
|
|---|---|---|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Lack of Efficacy
|
5
|
8
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Physician Decision
|
3
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Could not be weaned from steroid therapy
|
1
|
1
|
|
Overall Study
Treatment refused
|
0
|
6
|
Baseline Characteristics
Cyclophosphamide and Prednisone With or Without Immunoglobulin in Treating Abnormal Muscle Movement in Children With Neuroblastoma
Baseline characteristics by cohort
| Measure |
Arm I (Chemotherapy, Immunoglobulin Therapy)
n=26 Participants
Patients with intermediate-risk or high-risk neuroblastoma receive chemotherapy (including cyclophosphamide) according to the standard of care for the stage of primary neuroblastoma, beginning day 0. Patients with low-risk neuroblastoma (and not receiving other chemotherapy) receive cyclophosphamide IV over 1 hr on day 0. Treatment repeats every 4 wks for 6 courses in the absence of disease progression or unacceptable toxicity. All patients receive oral prednisone twice daily for 3 mths and then every other day for 7-15 mths.
Patients receive therapeutic immune globulin IV on days -2 and -1, at wks 4, 8, 12, 16, 20, and 24, and then at mths 8, 10, and 12 after therapy. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients with no response after 6 months go off treatment. In case of progression of opsoclonus-myoclonus-ataxia (OMA) during evaluation, patient will be switched to another steroid, corticotropin-releasing hormone (ACTH).
|
Arm II (Chemotherapy, Observation)
n=27 Participants
Patients with intermediate-risk or high-risk neuroblastoma receive chemotherapy (including cyclophosphamide) according to the standard of care for the stage of primary neuroblastoma, beginning on day 0. Patients with low-risk neuroblastoma (and not receiving other chemotherapy) receive cyclophosphamide IV over 1 hour on day 0. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. All patients receive oral prednisone twice daily for 3 months and then every other day for 7-15 months.
Patients do not receive therapeutic immune globulin. Patients with unresponsive opsoclonus-myoclonus-ataxia syndrome after 2 months or progression after 6 months may cross over to arm I.
|
Total
n=53 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
26 Participants
n=39 Participants
|
27 Participants
n=41 Participants
|
53 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Continuous
|
1.4 years
STANDARD_DEVIATION 0.9 • n=39 Participants
|
1.2 years
STANDARD_DEVIATION 0.5 • n=41 Participants
|
1.3 years
STANDARD_DEVIATION 0.7 • n=35 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=39 Participants
|
15 Participants
n=41 Participants
|
33 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=39 Participants
|
12 Participants
n=41 Participants
|
20 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=39 Participants
|
7 Participants
n=41 Participants
|
12 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=39 Participants
|
20 Participants
n=41 Participants
|
40 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
11 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=39 Participants
|
17 Participants
n=41 Participants
|
36 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=39 Participants
|
27 participants
n=41 Participants
|
53 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Changes from baseline to 2 months, 6 months, and 1 yearPopulation: Eligible patients
A multi-stage design followed by a test of proportions between the treatment arms (chemo vs. chemo + therapeutic immune globulin (IVIG)) will be performed. The first stage of the multi-stage design will also function as an early stopping rule for insufficient activity of chemotherapy in OMA.
Outcome measures
| Measure |
Arm I (Chemotherapy, Immunoglobulin Therapy)
n=26 Participants
Patients with intermediate-risk or high-risk neuroblastoma receive chemotherapy (including cyclophosphamide) according to the standard of care for the stage of primary neuroblastoma, beginning day 0. Patients with low-risk neuroblastoma (and not receiving other chemotherapy) receive cyclophosphamide IV over 1 hr on day 0. Treatment repeats every 4 wks for 6 courses in the absence of disease progression or unacceptable toxicity. All patients receive oral prednisone twice daily for 3 mths and then every other day for 7-15 mths.
Patients receive therapeutic immune globulin IV on days -2 and -1, at wks 4, 8, 12, 16, 20, and 24, and then at mths 8, 10, and 12 after therapy. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients with no response after 6 months go off treatment. In case of progression of opsoclonus-myoclonus-ataxia (OMA) during evaluation, patient will be switched to another steroid, corticotropin-releasing hormone (ACTH).
|
Arm II (Chemotherapy, Observation)
n=26 Participants
Patients with intermediate-risk or high-risk neuroblastoma receive chemotherapy (including cyclophosphamide) according to the standard of care for the stage of primary neuroblastoma, beginning on day 0. Patients with low-risk neuroblastoma (and not receiving other chemotherapy) receive cyclophosphamide IV over 1 hour on day 0. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. All patients receive oral prednisone twice daily for 3 months and then every other day for 7-15 months.
Patients do not receive therapeutic immune globulin. Patients with unresponsive opsoclonus-myoclonus-ataxia syndrome after 2 months or progression after 6 months may cross over to arm I.
|
|---|---|---|
|
Number of Responders
|
21 participants
|
11 participants
|
SECONDARY outcome
Timeframe: Changes from baseline to the better of 6 months or 1 yearPopulation: All eligible patients who had VABS measures at diagnosis and at least one of 6 months or 1 year.
The "best" score at the two time points will be used in this analysis. For a given patient, this "best" score will be used to calculate the change from baseline. The mean change from baseline for each treatment group will be calculated.
Outcome measures
| Measure |
Arm I (Chemotherapy, Immunoglobulin Therapy)
n=17 Participants
Patients with intermediate-risk or high-risk neuroblastoma receive chemotherapy (including cyclophosphamide) according to the standard of care for the stage of primary neuroblastoma, beginning day 0. Patients with low-risk neuroblastoma (and not receiving other chemotherapy) receive cyclophosphamide IV over 1 hr on day 0. Treatment repeats every 4 wks for 6 courses in the absence of disease progression or unacceptable toxicity. All patients receive oral prednisone twice daily for 3 mths and then every other day for 7-15 mths.
Patients receive therapeutic immune globulin IV on days -2 and -1, at wks 4, 8, 12, 16, 20, and 24, and then at mths 8, 10, and 12 after therapy. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients with no response after 6 months go off treatment. In case of progression of opsoclonus-myoclonus-ataxia (OMA) during evaluation, patient will be switched to another steroid, corticotropin-releasing hormone (ACTH).
|
Arm II (Chemotherapy, Observation)
n=11 Participants
Patients with intermediate-risk or high-risk neuroblastoma receive chemotherapy (including cyclophosphamide) according to the standard of care for the stage of primary neuroblastoma, beginning on day 0. Patients with low-risk neuroblastoma (and not receiving other chemotherapy) receive cyclophosphamide IV over 1 hour on day 0. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. All patients receive oral prednisone twice daily for 3 months and then every other day for 7-15 months.
Patients do not receive therapeutic immune globulin. Patients with unresponsive opsoclonus-myoclonus-ataxia syndrome after 2 months or progression after 6 months may cross over to arm I.
|
|---|---|---|
|
Motor Coordination as Assessed by Neurological Examination and Vineland Adaptive Behavior Scale (VABS)
|
84.53 Change in VABS score
Standard Deviation 115.91
|
144.73 Change in VABS score
Standard Deviation 110.69
|
SECONDARY outcome
Timeframe: Changes from baseline to the better of 6 months or 1 yearPopulation: All eligible patients who had Bayley's measures at diagnosis and at least one of 6 months or 1 year.
The Bayley Scales of infant development mental scale "best" score of two time points will be used in the analysis. For a given patient, this score will be used to calculate the change from baseline.
Outcome measures
| Measure |
Arm I (Chemotherapy, Immunoglobulin Therapy)
n=4 Participants
Patients with intermediate-risk or high-risk neuroblastoma receive chemotherapy (including cyclophosphamide) according to the standard of care for the stage of primary neuroblastoma, beginning day 0. Patients with low-risk neuroblastoma (and not receiving other chemotherapy) receive cyclophosphamide IV over 1 hr on day 0. Treatment repeats every 4 wks for 6 courses in the absence of disease progression or unacceptable toxicity. All patients receive oral prednisone twice daily for 3 mths and then every other day for 7-15 mths.
Patients receive therapeutic immune globulin IV on days -2 and -1, at wks 4, 8, 12, 16, 20, and 24, and then at mths 8, 10, and 12 after therapy. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients with no response after 6 months go off treatment. In case of progression of opsoclonus-myoclonus-ataxia (OMA) during evaluation, patient will be switched to another steroid, corticotropin-releasing hormone (ACTH).
|
Arm II (Chemotherapy, Observation)
n=4 Participants
Patients with intermediate-risk or high-risk neuroblastoma receive chemotherapy (including cyclophosphamide) according to the standard of care for the stage of primary neuroblastoma, beginning on day 0. Patients with low-risk neuroblastoma (and not receiving other chemotherapy) receive cyclophosphamide IV over 1 hour on day 0. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. All patients receive oral prednisone twice daily for 3 months and then every other day for 7-15 months.
Patients do not receive therapeutic immune globulin. Patients with unresponsive opsoclonus-myoclonus-ataxia syndrome after 2 months or progression after 6 months may cross over to arm I.
|
|---|---|---|
|
Functional Outcome as Assessed by Age-appropriate Neuropsychological Testing
|
117.5 Change in Bayley's score
Standard Deviation 35.35
|
100.75 Change in Bayley's score
Standard Deviation 25.76
|
SECONDARY outcome
Timeframe: At diagnosis, 6 months, 1 year, 5 and 10 years after diagnosisPopulation: The necessary data will never be collected, therefore results can't be provided.
Descriptive analyses on biologic variables will be performed
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At diagnosis and yearly for 10 years after diagnosisPopulation: The necessary data will never be collected, therefore results can't be provided.
A t-test will be performed on the results of each neurologic test, comparing patients who have had disappearance of anti-neural antibodies to patients whose anti-neural antibodies have not disappeared.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: All eligible randomized patients.
EFS rate for neuroblastoma event from time of study enrollment.
Outcome measures
| Measure |
Arm I (Chemotherapy, Immunoglobulin Therapy)
n=26 Participants
Patients with intermediate-risk or high-risk neuroblastoma receive chemotherapy (including cyclophosphamide) according to the standard of care for the stage of primary neuroblastoma, beginning day 0. Patients with low-risk neuroblastoma (and not receiving other chemotherapy) receive cyclophosphamide IV over 1 hr on day 0. Treatment repeats every 4 wks for 6 courses in the absence of disease progression or unacceptable toxicity. All patients receive oral prednisone twice daily for 3 mths and then every other day for 7-15 mths.
Patients receive therapeutic immune globulin IV on days -2 and -1, at wks 4, 8, 12, 16, 20, and 24, and then at mths 8, 10, and 12 after therapy. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients with no response after 6 months go off treatment. In case of progression of opsoclonus-myoclonus-ataxia (OMA) during evaluation, patient will be switched to another steroid, corticotropin-releasing hormone (ACTH).
|
Arm II (Chemotherapy, Observation)
n=27 Participants
Patients with intermediate-risk or high-risk neuroblastoma receive chemotherapy (including cyclophosphamide) according to the standard of care for the stage of primary neuroblastoma, beginning on day 0. Patients with low-risk neuroblastoma (and not receiving other chemotherapy) receive cyclophosphamide IV over 1 hour on day 0. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. All patients receive oral prednisone twice daily for 3 months and then every other day for 7-15 months.
Patients do not receive therapeutic immune globulin. Patients with unresponsive opsoclonus-myoclonus-ataxia syndrome after 2 months or progression after 6 months may cross over to arm I.
|
|---|---|---|
|
Tumor Outcome in Terms of Event-free Survival (EFS) Rate Defined as a Relapse or Progression of Neuroblastoma, a Second Malignancy, or Death
|
92.3 3 year EFS
Interval 81.8 to 100.0
|
96.0 3 year EFS
Interval 87.8 to 100.0
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: All eligible randomized patients.
OS rate from time of study enrollment.
Outcome measures
| Measure |
Arm I (Chemotherapy, Immunoglobulin Therapy)
n=26 Participants
Patients with intermediate-risk or high-risk neuroblastoma receive chemotherapy (including cyclophosphamide) according to the standard of care for the stage of primary neuroblastoma, beginning day 0. Patients with low-risk neuroblastoma (and not receiving other chemotherapy) receive cyclophosphamide IV over 1 hr on day 0. Treatment repeats every 4 wks for 6 courses in the absence of disease progression or unacceptable toxicity. All patients receive oral prednisone twice daily for 3 mths and then every other day for 7-15 mths.
Patients receive therapeutic immune globulin IV on days -2 and -1, at wks 4, 8, 12, 16, 20, and 24, and then at mths 8, 10, and 12 after therapy. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients with no response after 6 months go off treatment. In case of progression of opsoclonus-myoclonus-ataxia (OMA) during evaluation, patient will be switched to another steroid, corticotropin-releasing hormone (ACTH).
|
Arm II (Chemotherapy, Observation)
n=27 Participants
Patients with intermediate-risk or high-risk neuroblastoma receive chemotherapy (including cyclophosphamide) according to the standard of care for the stage of primary neuroblastoma, beginning on day 0. Patients with low-risk neuroblastoma (and not receiving other chemotherapy) receive cyclophosphamide IV over 1 hour on day 0. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. All patients receive oral prednisone twice daily for 3 months and then every other day for 7-15 months.
Patients do not receive therapeutic immune globulin. Patients with unresponsive opsoclonus-myoclonus-ataxia syndrome after 2 months or progression after 6 months may cross over to arm I.
|
|---|---|---|
|
Tumor Outcome in Terms of Overall Survival (OS) Rate
|
100 3 year OS
Interval 100.0 to 100.0
|
96.0 3 year OS
Interval 87.8 to 100.0
|
Adverse Events
Arm I (Chemotherapy, Immunoglobulin Therapy)
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Arm II (Chemotherapy, Observation)
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I (Chemotherapy, Immunoglobulin Therapy)
n=26 participants at risk
Patients with intermediate-risk or high-risk neuroblastoma receive chemotherapy (including cyclophosphamide) according to the standard of care for the stage of primary neuroblastoma, beginning day 0. Patients with low-risk neuroblastoma (and not receiving other chemotherapy) receive cyclophosphamide IV over 1 hr on day 0. Treatment repeats every 4 wks for 6 courses in the absence of disease progression or unacceptable toxicity. All patients receive oral prednisone twice daily for 3 mths and then every other day for 7-15 mths.
Patients receive therapeutic immune globulin IV on days -2 and -1, at wks 4, 8, 12, 16, 20, and 24, and then at mths 8, 10, and 12 after therapy. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients with no response after 6 months go off treatment. In case of progression of opsoclonus-myoclonus-ataxia (OMA) during evaluation, patient will be switched to another steroid, corticotropin-releasing hormone (ACTH).
|
Arm II (Chemotherapy, Observation)
n=27 participants at risk
Patients with intermediate-risk or high-risk neuroblastoma receive chemotherapy (including cyclophosphamide) according to the standard of care for the stage of primary neuroblastoma, beginning on day 0. Patients with low-risk neuroblastoma (and not receiving other chemotherapy) receive cyclophosphamide IV over 1 hour on day 0. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. All patients receive oral prednisone twice daily for 3 months and then every other day for 7-15 months.
Patients do not receive therapeutic immune globulin. Patients with unresponsive opsoclonus-myoclonus-ataxia syndrome after 2 months or progression after 6 months may cross over to arm I.
|
|---|---|---|
|
Infections and infestations
53100-Lung infection
|
0.00%
0/26
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
3.7%
1/27 • Number of events 1
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
|
Investigations
15000-Aspartate aminotransferase increased
|
3.8%
1/26 • Number of events 1
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
0.00%
0/27
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
Other adverse events
| Measure |
Arm I (Chemotherapy, Immunoglobulin Therapy)
n=26 participants at risk
Patients with intermediate-risk or high-risk neuroblastoma receive chemotherapy (including cyclophosphamide) according to the standard of care for the stage of primary neuroblastoma, beginning day 0. Patients with low-risk neuroblastoma (and not receiving other chemotherapy) receive cyclophosphamide IV over 1 hr on day 0. Treatment repeats every 4 wks for 6 courses in the absence of disease progression or unacceptable toxicity. All patients receive oral prednisone twice daily for 3 mths and then every other day for 7-15 mths.
Patients receive therapeutic immune globulin IV on days -2 and -1, at wks 4, 8, 12, 16, 20, and 24, and then at mths 8, 10, and 12 after therapy. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients with no response after 6 months go off treatment. In case of progression of opsoclonus-myoclonus-ataxia (OMA) during evaluation, patient will be switched to another steroid, corticotropin-releasing hormone (ACTH).
|
Arm II (Chemotherapy, Observation)
n=27 participants at risk
Patients with intermediate-risk or high-risk neuroblastoma receive chemotherapy (including cyclophosphamide) according to the standard of care for the stage of primary neuroblastoma, beginning on day 0. Patients with low-risk neuroblastoma (and not receiving other chemotherapy) receive cyclophosphamide IV over 1 hour on day 0. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. All patients receive oral prednisone twice daily for 3 months and then every other day for 7-15 months.
Patients do not receive therapeutic immune globulin. Patients with unresponsive opsoclonus-myoclonus-ataxia syndrome after 2 months or progression after 6 months may cross over to arm I.
|
|---|---|---|
|
Blood and lymphatic system disorders
13200-Anemia
|
3.8%
1/26 • Number of events 3
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
14.8%
4/27 • Number of events 6
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
|
Blood and lymphatic system disorders
33300-Febrile neutropenia
|
3.8%
1/26 • Number of events 2
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
3.7%
1/27 • Number of events 3
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
|
Cardiac disorders
74200-Sinus bradycardia
|
0.00%
0/26
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
3.7%
1/27 • Number of events 1
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
|
Endocrine disorders
11200-Adrenal insufficiency
|
0.00%
0/26
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
3.7%
1/27 • Number of events 1
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
|
Endocrine disorders
24200-Cushingoid
|
0.00%
0/26
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
7.4%
2/27 • Number of events 3
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
|
Gastrointestinal disorders
22100-Colitis
|
0.00%
0/26
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
3.7%
1/27 • Number of events 1
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
|
Gastrointestinal disorders
25700-Diarrhea
|
3.8%
1/26 • Number of events 1
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
0.00%
0/27
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
|
Gastrointestinal disorders
31200-Esophagitis
|
0.00%
0/26
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
3.7%
1/27 • Number of events 1
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
|
Gastrointestinal disorders
36700-Gastrointestinal disorders - Other specify
|
0.00%
0/26
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
3.7%
1/27 • Number of events 1
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
|
Gastrointestinal disorders
46300-Intra-abdominal hemorrhage(targeted toxicity)
|
0.00%
0/26
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
3.7%
1/27 • Number of events 1
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
|
Gastrointestinal disorders
55600-Mucositis oral
|
0.00%
0/26
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
3.7%
1/27 • Number of events 1
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
|
Gastrointestinal disorders
57600-Nausea(targeted toxicity)
|
3.8%
1/26 • Number of events 1
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
7.4%
2/27 • Number of events 5
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
|
Gastrointestinal disorders
87900-Vomiting(targeted toxicity)
|
19.2%
5/26 • Number of events 6
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
18.5%
5/27 • Number of events 10
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
|
General disorders
33900-Fever
|
3.8%
1/26 • Number of events 1
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
3.7%
1/27 • Number of events 1
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
|
General disorders
48700-Irritability
|
0.00%
0/26
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
11.1%
3/27 • Number of events 4
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
|
Infections and infestations
16800-Bladder infection
|
7.7%
2/26 • Number of events 2
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
3.7%
1/27 • Number of events 1
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
|
Infections and infestations
20500-Catheter related infection
|
3.8%
1/26 • Number of events 1
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
7.4%
2/27 • Number of events 2
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
|
Infections and infestations
29500-Enterocolitis infectious
|
0.00%
0/26
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
3.7%
1/27 • Number of events 1
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
|
Infections and infestations
44800-Infections and infestations - Other specify
|
7.7%
2/26 • Number of events 2
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
25.9%
7/27 • Number of events 14
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
|
Infections and infestations
82300-Upper respiratory infection
|
0.00%
0/26
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
3.7%
1/27 • Number of events 1
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
|
Infections and infestations
83100-Urinary tract infection
|
0.00%
0/26
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
3.7%
1/27 • Number of events 1
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
|
Injury, poisoning and procedural complications
34900-Fracture
|
0.00%
0/26
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
7.4%
2/27 • Number of events 2
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
|
Investigations
11600-Alanine aminotransferase increased
|
7.7%
2/26 • Number of events 4
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
0.00%
0/27
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
|
Investigations
15000-Aspartate aminotransferase increased
|
3.8%
1/26 • Number of events 1
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
0.00%
0/27
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
|
Investigations
53700-Lymphocyte count decreased
|
0.00%
0/26
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
3.7%
1/27 • Number of events 1
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
|
Investigations
58300-Neutrophil count decreased
|
3.8%
1/26 • Number of events 4
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
11.1%
3/27 • Number of events 8
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
|
Investigations
65800-Platelet count decreased
|
0.00%
0/26
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
3.7%
1/27 • Number of events 3
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
|
Investigations
88200-Weight gain
|
0.00%
0/26
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
3.7%
1/27 • Number of events 1
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
|
Investigations
88500-White blood cell decreased
|
3.8%
1/26 • Number of events 4
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
7.4%
2/27 • Number of events 3
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
|
Metabolism and nutrition disorders
13500-Anorexia
|
3.8%
1/26 • Number of events 2
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
0.00%
0/27
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
|
Metabolism and nutrition disorders
24700-Dehydration
|
0.00%
0/26
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
7.4%
2/27 • Number of events 2
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
|
Metabolism and nutrition disorders
41300-Hypercalcemia
|
3.8%
1/26 • Number of events 1
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
0.00%
0/27
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
|
Metabolism and nutrition disorders
41400-Hyperglycemia(targeted toxicity)
|
3.8%
1/26 • Number of events 2
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
14.8%
4/27 • Number of events 6
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
|
Metabolism and nutrition disorders
41600-Hyperkalemia
|
3.8%
1/26 • Number of events 1
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
0.00%
0/27
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
|
Metabolism and nutrition disorders
42600-Hypoalbuminemia
|
3.8%
1/26 • Number of events 2
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
0.00%
0/27
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
|
Metabolism and nutrition disorders
42700-Hypocalcemia
|
3.8%
1/26 • Number of events 3
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
3.7%
1/27 • Number of events 3
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
|
Metabolism and nutrition disorders
42900-Hypoglycemia
|
0.00%
0/26
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
3.7%
1/27 • Number of events 1
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
|
Metabolism and nutrition disorders
43100-Hypokalemia
|
3.8%
1/26 • Number of events 1
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
7.4%
2/27 • Number of events 3
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
|
Metabolism and nutrition disorders
43300-Hyponatremia
|
0.00%
0/26
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
3.7%
1/27 • Number of events 1
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
|
Metabolism and nutrition disorders
43500-Hypophosphatemia
|
0.00%
0/26
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
7.4%
2/27 • Number of events 3
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
|
Nervous system disorders
15300-Ataxia
|
3.8%
1/26 • Number of events 1
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
14.8%
4/27 • Number of events 6
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
|
Nervous system disorders
58700-Nystagmus
|
7.7%
2/26 • Number of events 3
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
33.3%
9/27 • Number of events 14
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
|
Nervous system disorders
69300-Pyramidal tract syndrome
|
0.00%
0/26
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
3.7%
1/27 • Number of events 1
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
|
Psychiatric disorders
11400-Agitation
|
15.4%
4/26 • Number of events 8
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
40.7%
11/27 • Number of events 25
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
|
Psychiatric disorders
13700-Anxiety(targeted toxicity)
|
0.00%
0/26
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
3.7%
1/27 • Number of events 1
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
|
Psychiatric disorders
64400-Personality change
|
3.8%
1/26 • Number of events 1
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
0.00%
0/27
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
|
Respiratory, thoracic and mediastinal disorders
43900-Hypoxia
|
0.00%
0/26
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
3.7%
1/27 • Number of events 1
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
|
Skin and subcutaneous tissue disorders
41500-Hyperhidrosis
|
3.8%
1/26 • Number of events 1
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
0.00%
0/27
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
|
Skin and subcutaneous tissue disorders
69700-Rash maculo-papular(targeted toxicity)
|
3.8%
1/26 • Number of events 1
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
0.00%
0/27
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
|
Vascular disorders
42100-Hypertension
|
0.00%
0/26
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
11.1%
3/27 • Number of events 7
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
|
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