Trial Outcomes & Findings for ABT-751 in Treating Children With Neuroblastoma That Has Relapsed or Not Responded to Previous Treatment (NCT NCT00436852)
NCT ID: NCT00436852
Last Updated: 2019-07-17
Results Overview
Median time to progression observed on ABT-751, along with 95% confidence intervals.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
92 participants
Primary outcome timeframe
From time to enrollment to death due to any cause, assessed up to 5.1 years
Results posted on
2019-07-17
Participant Flow
Participant milestones
| Measure |
Disease Evaluable by I-MIBG Scintigraphy (ABT-751)
Patients receive oral ABT-751 (200 mg/m2) once daily on days 1-7. Treatment repeats every 21 days for 52 courses in the absence of disease progression or unacceptable toxicity. Quality-of-life assessment at baseline and prior to each course of treatment. A pharmacological study (pharmacokinetic profile of ABT-751) will be determined.
|
Measurable Disease by CT or MRI Scan (ABT-751)
Patients receive oral ABT-751 (200 mg/m2) once daily on days 1-7. Treatment repeats every 21 days for 52 courses in the absence of disease progression or unacceptable toxicity. Quality-of-life assessment at baseline and prior to each course of treatment. A pharmacological study (pharmacokinetic profile of ABT-751) will be determined.
|
|---|---|---|
|
Overall Study
STARTED
|
45
|
47
|
|
Overall Study
COMPLETED
|
10
|
2
|
|
Overall Study
NOT COMPLETED
|
35
|
45
|
Reasons for withdrawal
| Measure |
Disease Evaluable by I-MIBG Scintigraphy (ABT-751)
Patients receive oral ABT-751 (200 mg/m2) once daily on days 1-7. Treatment repeats every 21 days for 52 courses in the absence of disease progression or unacceptable toxicity. Quality-of-life assessment at baseline and prior to each course of treatment. A pharmacological study (pharmacokinetic profile of ABT-751) will be determined.
|
Measurable Disease by CT or MRI Scan (ABT-751)
Patients receive oral ABT-751 (200 mg/m2) once daily on days 1-7. Treatment repeats every 21 days for 52 courses in the absence of disease progression or unacceptable toxicity. Quality-of-life assessment at baseline and prior to each course of treatment. A pharmacological study (pharmacokinetic profile of ABT-751) will be determined.
|
|---|---|---|
|
Overall Study
Death
|
23
|
34
|
|
Overall Study
Lack of Efficacy
|
9
|
7
|
|
Overall Study
Withdrawal by Subject
|
2
|
4
|
|
Overall Study
Ineligible
|
1
|
0
|
Baseline Characteristics
ABT-751 in Treating Children With Neuroblastoma That Has Relapsed or Not Responded to Previous Treatment
Baseline characteristics by cohort
| Measure |
Disease Evaluable by I-MIBG Scintigraphy (ABT-751)
n=45 Participants
Patients receive oral ABT-751 (200 mg/m2) once daily on days 1-7. Treatment repeats every 21 days for 52 courses in the absence of disease progression or unacceptable toxicity. Quality-of-life assessment at baseline and prior to each course of treatment. A pharmacological study (pharmacokinetic profile of ABT-751) will be determined.
|
Measurable Disease by CT or MRI Scan (ABT-751)
n=47 Participants
Patients receive oral ABT-751 (200 mg/m2) once daily on days 1-7. Treatment repeats every 21 days for 52 courses in the absence of disease progression or unacceptable toxicity. Quality-of-life assessment at baseline and prior to each course of treatment. A pharmacological study (pharmacokinetic profile of ABT-751) will be determined.
|
Total
n=92 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
42 Participants
n=99 Participants
|
45 Participants
n=107 Participants
|
87 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
8.46 years
n=99 Participants
|
7.55 years
n=107 Participants
|
8.00 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
57 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
35 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
76 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
60 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
45 participants
n=99 Participants
|
36 participants
n=107 Participants
|
81 participants
n=206 Participants
|
|
Region of Enrollment
Canada
|
0 participants
n=99 Participants
|
10 participants
n=107 Participants
|
10 participants
n=206 Participants
|
|
Region of Enrollment
Jamaica
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: From time to enrollment to death due to any cause, assessed up to 5.1 yearsPopulation: The protocol-specified definition of evaluability was applied. This was not an intention-to-treat analysis because patients who did not receive study drug were excluded (inevaluable).
Median time to progression observed on ABT-751, along with 95% confidence intervals.
Outcome measures
| Measure |
Disease Evaluable by I-MIBG Scintigraphy (ABT-751)
n=44 Participants
Patients who met study eligibility criteria and receive at least one dose of oral ABT-751 were evaluable for the efficacy analysis.
|
Measurable Disease by CT or MRI Scan (ABT-751)
n=47 Participants
Patients who met study eligibility criteria and receive at least one dose of oral ABT-751 were evaluable for the efficacy analysis.
|
|---|---|---|
|
Median Time to Progression as Assessed by Response Evaluation Criteria in Solid Tumors
|
45 days
Interval 42.0 to 85.0
|
42 days
Interval 36.0 to 56.0
|
PRIMARY outcome
Timeframe: From the day of enrollment to the date of disease progression/recurrence , or the date of death (all causes of mortality) if disease progression/recurrence is not reached, assessed up to 1 yr. Pts were to be followed for 5 yrs after completion of therapyPopulation: The protocol-specified definition of evaluability was applied. This was not an intention-to-treat analysis because patients who did not receive study drug were excluded (inevaluable).
PFS probabilities calculated using the Kaplan-Meier method, along 95% confidence intervals, separately for each stratum.
Outcome measures
| Measure |
Disease Evaluable by I-MIBG Scintigraphy (ABT-751)
n=44 Participants
Patients who met study eligibility criteria and receive at least one dose of oral ABT-751 were evaluable for the efficacy analysis.
|
Measurable Disease by CT or MRI Scan (ABT-751)
n=47 Participants
Patients who met study eligibility criteria and receive at least one dose of oral ABT-751 were evaluable for the efficacy analysis.
|
|---|---|---|
|
1-year Progression-free Survival
|
19 percent probability
Interval 7.0 to 31.0
|
7 percent probability
Interval 0.0 to 15.0
|
SECONDARY outcome
Timeframe: Duration of protocol therapy, up to 3 yearsPopulation: Patients who met study eligibility criteria and received at least one dose of oral ABT-751 were evaluable for the response analysis.
The percentage of patients who are responders will be tabulated, including a 95% confidence interval on the percentage. Responders were defined as patients who achieved a best overall response of complete response (CR) or partial response (PR) at any time on the study including patients who achieved ≥PR and later had progressive disease or relapse. Response in patients with measurable disease will be assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 or by Curie criteria for measuring response by MIBG scans in patients with evaluable disease by 123I-MIBG scan. Per RECIST: CR= Disappearance of all target lesions; PR= at least 30% decrease in the sum of the longest diameter of target lesions. Per Curie criteria: CR= complete resolution of all MIBG positive lesions; PR= resolution of at least one MIBG positive lesion with persistence of other MIBG positive lesions.
Outcome measures
| Measure |
Disease Evaluable by I-MIBG Scintigraphy (ABT-751)
n=43 Participants
Patients who met study eligibility criteria and receive at least one dose of oral ABT-751 were evaluable for the efficacy analysis.
|
Measurable Disease by CT or MRI Scan (ABT-751)
n=47 Participants
Patients who met study eligibility criteria and receive at least one dose of oral ABT-751 were evaluable for the efficacy analysis.
|
|---|---|---|
|
Objective Response Rate
|
12 Percentage of patients
Interval 2.0 to 21.0
|
2 Percentage of patients
Interval 0.0 to 6.0
|
SECONDARY outcome
Timeframe: At baselinePopulation: Eligible patients with a QOL evaluation at baseline were included in the analysis.
The QOL score will be reverse linearly transformed to a 0-100 percentage point scale (0=100, 1=75, 2=50, 3=25, 4=0), with higher scores indicating better health-related quality of life, and the average of all 23 items will be calculated as the composite score.
Outcome measures
| Measure |
Disease Evaluable by I-MIBG Scintigraphy (ABT-751)
n=37 Participants
Patients who met study eligibility criteria and receive at least one dose of oral ABT-751 were evaluable for the efficacy analysis.
|
Measurable Disease by CT or MRI Scan (ABT-751)
n=34 Participants
Patients who met study eligibility criteria and receive at least one dose of oral ABT-751 were evaluable for the efficacy analysis.
|
|---|---|---|
|
Quality of Life Measured by PedsQL™ Generic Core Scale Version 4.0
|
80 Scores on a scale
Interval 44.0 to 99.0
|
68 Scores on a scale
Interval 29.0 to 100.0
|
SECONDARY outcome
Timeframe: From enrollment until 30 days after the end of protocol therapyPopulation: All eligible patients who received at least 1 dose of ABT-751 were evaluable for toxicity and included in the analysis.
Percentage of patients with at least one Grade 3 or higher toxicity, as assessed by Common Terminology Criteria for Adverse Events version 3.0, will be tabulated.
Outcome measures
| Measure |
Disease Evaluable by I-MIBG Scintigraphy (ABT-751)
n=44 Participants
Patients who met study eligibility criteria and receive at least one dose of oral ABT-751 were evaluable for the efficacy analysis.
|
Measurable Disease by CT or MRI Scan (ABT-751)
n=47 Participants
Patients who met study eligibility criteria and receive at least one dose of oral ABT-751 were evaluable for the efficacy analysis.
|
|---|---|---|
|
Percentage of Participants With Grade 3 or Higher Toxicity
|
75.0 Percentage of patients
|
72.3 Percentage of patients
|
SECONDARY outcome
Timeframe: After the first dose of ABT-751, at 0.5, 1, 2, 3, 5, 8, 10-12, and 24 hours post-dose.Population: All eligible patients from Group 1 (Disease Evaluable by I-MIBG Scintigraphy (ABT-751)) and Group 2 (Measurable Disease by CT or MRI Scan (ABT-751)) who received the first dose of ABT-751 and participated in the pharmacokinetic studies were included in the analysis and are presented as a single Group, as the interest was in both groups combined.
Values of the maximum observed concentration (Cmax) will be determined for the first dose.Descriptive statistics for these variables will be provided.
Outcome measures
| Measure |
Disease Evaluable by I-MIBG Scintigraphy (ABT-751)
n=16 Participants
Patients who met study eligibility criteria and receive at least one dose of oral ABT-751 were evaluable for the efficacy analysis.
|
Measurable Disease by CT or MRI Scan (ABT-751)
Patients who met study eligibility criteria and receive at least one dose of oral ABT-751 were evaluable for the efficacy analysis.
|
|---|---|---|
|
Pharmacokinetics of ABT-751: Cmax
|
15.3 mg/ml
Interval 7.3 to 22.4
|
—
|
SECONDARY outcome
Timeframe: After the first dose of ABT-751, at 0.5, 1, 2, 3, 5, 8, 10-12, and 24 hours post-dose.Population: All eligible patients from Group 1 (Disease Evaluable by I-MIBG Scintigraphy (ABT-751)) and Group 2 (Measurable Disease by CT or MRI Scan (ABT-751)) who received the first dose of ABT-751 and participated in the pharmacokinetic studies were included in the analysis and are presented as a single Group, as the interest was in both groups combined.
Values of the time to maximum observed concentration (Tmax) will be determined for the first dose.Descriptive statistics for these variables will be provided.
Outcome measures
| Measure |
Disease Evaluable by I-MIBG Scintigraphy (ABT-751)
n=16 Participants
Patients who met study eligibility criteria and receive at least one dose of oral ABT-751 were evaluable for the efficacy analysis.
|
Measurable Disease by CT or MRI Scan (ABT-751)
Patients who met study eligibility criteria and receive at least one dose of oral ABT-751 were evaluable for the efficacy analysis.
|
|---|---|---|
|
Pharmacokinetics of ABT-751: Tmax
|
1 hours
Interval 1.0 to 3.0
|
—
|
SECONDARY outcome
Timeframe: After the first dose of ABT-751, at 0.5, 1, 2, 3, 5, 8, 10-12, and 24 hours post-dose.Population: All eligible patients from Group 1 (Disease Evaluable by I-MIBG Scintigraphy (ABT-751)) and Group 2 (Measurable Disease by CT or MRI Scan (ABT-751)) who received the first dose of ABT-751 and participated in the pharmacokinetic studies were included in the analysis and are presented as a single Group, as the interest was in both groups combined.
Values of the area under concentration time curve \[AUC(0-∞)\] will be determined for the first dose. Descriptive statistics for these variables will be provided.
Outcome measures
| Measure |
Disease Evaluable by I-MIBG Scintigraphy (ABT-751)
n=16 Participants
Patients who met study eligibility criteria and receive at least one dose of oral ABT-751 were evaluable for the efficacy analysis.
|
Measurable Disease by CT or MRI Scan (ABT-751)
Patients who met study eligibility criteria and receive at least one dose of oral ABT-751 were evaluable for the efficacy analysis.
|
|---|---|---|
|
Pharmacokinetics of ABT-751: AUC
|
77.5 mg·hours/ml
Interval 46.8 to 169.3
|
—
|
Adverse Events
Disease Evaluable by I-MIBG Scintigraphy (ABT-751)
Serious events: 3 serious events
Other events: 17 other events
Deaths: 0 deaths
Measurable Disease by CT or MRI Scan (ABT-751)
Serious events: 4 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Disease Evaluable by I-MIBG Scintigraphy (ABT-751)
n=44 participants at risk
Patients who met study eligibility criteria and receive at least one dose of oral ABT-751 were evaluable for the efficacy analysis.
|
Measurable Disease by CT or MRI Scan (ABT-751)
n=47 participants at risk
Patients who met study eligibility criteria and receive at least one dose of oral ABT-751 were evaluable for the efficacy analysis.
|
|---|---|---|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
2.3%
1/44
|
0.00%
0/47
|
|
Respiratory, thoracic and mediastinal disorders
" Bronchospasm, wheezing"
|
2.3%
1/44
|
0.00%
0/47
|
|
Metabolism and nutrition disorders
Anorexia
|
2.3%
1/44
|
2.1%
1/47
|
|
Gastrointestinal disorders
Constipation
|
4.5%
2/44
|
4.3%
2/47
|
|
General disorders
Death not associated with CTCAE term - Death NOS
|
2.3%
1/44
|
0.00%
0/47
|
|
General disorders
Death not associated with CTCAE term - Disease progression NOS
|
0.00%
0/44
|
2.1%
1/47
|
|
Metabolism and nutrition disorders
Dehydration
|
2.3%
1/44
|
0.00%
0/47
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
0.00%
0/44
|
2.1%
1/47
|
|
Blood and lymphatic system disorders
Febrile neutropenia (fever, unk. origin,w/o infection,ANC<1x10e9, fever>=38.5C)
|
0.00%
0/44
|
4.3%
2/47
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
2.3%
1/44
|
2.1%
1/47
|
|
General disorders
Gait/walking: Extremity-lower (gait/walking)
|
0.00%
0/44
|
2.1%
1/47
|
|
Blood and lymphatic system disorders
Hemoglobin
|
2.3%
1/44
|
4.3%
2/47
|
|
Gastrointestinal disorders
Hemorrhage, GI - Rectum
|
2.3%
1/44
|
0.00%
0/47
|
|
Vascular disorders
Hypertension
|
0.00%
0/44
|
2.1%
1/47
|
|
Metabolism and nutrition disorders
Hypoglycemia: Glucose, serum-low (hypoglycemia)
|
0.00%
0/44
|
2.1%
1/47
|
|
Metabolism and nutrition disorders
Hypokalemia: Potassium, serum-low (hypokalemia)
|
0.00%
0/44
|
4.3%
2/47
|
|
Metabolism and nutrition disorders
Hyponatremia: Sodium, serum-low (hyponatremia)
|
0.00%
0/44
|
2.1%
1/47
|
|
Vascular disorders
Hypotension
|
2.3%
1/44
|
0.00%
0/47
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/44
|
2.1%
1/47
|
|
Infections and infestations
Infection (clinical or microbiological Dx) w/ Gr 3-4 neutrophils, ANC<1.0x10e9 - Blood
|
0.00%
0/44
|
2.1%
1/47
|
|
Infections and infestations
Infection (clinical or microbiological Dx) w/ Gr 3-4 neutrophils, ANC<1.0x10e9 - Paranasal
|
2.3%
1/44
|
0.00%
0/47
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Blood
|
4.5%
2/44
|
0.00%
0/47
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Bone (osteomyelitis)
|
0.00%
0/44
|
2.1%
1/47
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Catheter-related
|
2.3%
1/44
|
2.1%
1/47
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Sinus
|
0.00%
0/44
|
2.1%
1/47
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Skin (cellulitis)
|
4.5%
2/44
|
0.00%
0/47
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Upper airway NOS
|
4.5%
2/44
|
0.00%
0/47
|
|
Infections and infestations
Infection with unknown ANC - Blood
|
0.00%
0/44
|
2.1%
1/47
|
|
Infections and infestations
Infection with unknown ANC - Middle ear (otitis media)
|
2.3%
1/44
|
0.00%
0/47
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/44
|
2.1%
1/47
|
|
Cardiac disorders
Left ventricular diastolic dysfunction
|
0.00%
0/44
|
2.1%
1/47
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
2.3%
1/44
|
2.1%
1/47
|
|
Psychiatric disorders
Mood alteration - Agitation
|
2.3%
1/44
|
0.00%
0/47
|
|
Psychiatric disorders
Mood alteration - Anxiety
|
0.00%
0/44
|
2.1%
1/47
|
|
Psychiatric disorders
Mood alteration - Depression
|
0.00%
0/44
|
2.1%
1/47
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy) - Whole body/generalized
|
2.3%
1/44
|
0.00%
0/47
|
|
Nervous system disorders
Neuropathy: sensory
|
2.3%
1/44
|
8.5%
4/47
|
|
Gastrointestinal disorders
Obstruction, GI - Small bowel NOS
|
0.00%
0/44
|
4.3%
2/47
|
|
Gastrointestinal disorders
Pain - Abdomen NOS
|
2.3%
1/44
|
0.00%
0/47
|
|
Musculoskeletal and connective tissue disorders
Pain - Bone
|
2.3%
1/44
|
0.00%
0/47
|
|
Musculoskeletal and connective tissue disorders
Pain - Extremity-limb
|
6.8%
3/44
|
6.4%
3/47
|
|
Nervous system disorders
Pain - Head/headache
|
0.00%
0/44
|
2.1%
1/47
|
|
Musculoskeletal and connective tissue disorders
Pain - Muscle
|
0.00%
0/44
|
2.1%
1/47
|
|
Nervous system disorders
Pain - Neuralgia/peripheral nerve
|
0.00%
0/44
|
6.4%
3/47
|
|
Psychiatric disorders
Personality/behavioral
|
2.3%
1/44
|
0.00%
0/47
|
|
Investigations
Platelets
|
2.3%
1/44
|
0.00%
0/47
|
|
Nervous system disorders
Syncope (fainting)
|
2.3%
1/44
|
0.00%
0/47
|
|
Nervous system disorders
Taste alteration (dysgeusia)
|
0.00%
0/44
|
2.1%
1/47
|
|
Gastrointestinal disorders
Vomiting
|
2.3%
1/44
|
4.3%
2/47
|
|
Investigations
Weight loss
|
2.3%
1/44
|
0.00%
0/47
|
Other adverse events
| Measure |
Disease Evaluable by I-MIBG Scintigraphy (ABT-751)
n=44 participants at risk
Patients who met study eligibility criteria and receive at least one dose of oral ABT-751 were evaluable for the efficacy analysis.
|
Measurable Disease by CT or MRI Scan (ABT-751)
n=47 participants at risk
Patients who met study eligibility criteria and receive at least one dose of oral ABT-751 were evaluable for the efficacy analysis.
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
18.2%
8/44 • Number of events 8
|
25.5%
12/47 • Number of events 12
|
|
Metabolism and nutrition disorders
Anorexia
|
15.9%
7/44 • Number of events 7
|
19.1%
9/47 • Number of events 9
|
|
Investigations
"ALT, SGPT (serum glutamic pyruvic transaminase)"
|
20.5%
9/44 • Number of events 9
|
29.8%
14/47 • Number of events 14
|
|
Investigations
"AST: AST, SGOT(serum glutamic oxaloacetic transaminase)"
|
15.9%
7/44 • Number of events 7
|
29.8%
14/47 • Number of events 14
|
|
Metabolism and nutrition disorders
"Albumin, serum-low (hypoalbuminemia)"
|
0.00%
0/44
|
25.5%
12/47 • Number of events 12
|
|
Metabolism and nutrition disorders
"Bicarbonate, serum-low"
|
0.00%
0/44
|
8.5%
4/47 • Number of events 4
|
|
Investigations
" Cholesterol: Cholesterol, serum-high (hypercholestremia)"
|
0.00%
0/44
|
6.4%
3/47 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.1%
4/44 • Number of events 4
|
8.5%
4/47 • Number of events 4
|
|
Investigations
Creatinine
|
0.00%
0/44
|
8.5%
4/47 • Number of events 4
|
|
Metabolism and nutrition disorders
Dehydration
|
9.1%
4/44 • Number of events 4
|
0.00%
0/47
|
|
Gastrointestinal disorders
Diarrhea
|
11.4%
5/44 • Number of events 5
|
17.0%
8/47 • Number of events 8
|
|
General disorders
" Fatigue (asthenia, lethargy, malaise)"
|
29.5%
13/44 • Number of events 13
|
19.1%
9/47 • Number of events 9
|
|
General disorders
" Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)"
|
13.6%
6/44 • Number of events 6
|
25.5%
12/47 • Number of events 12
|
|
Investigations
GGT: GGT (gamma-Glutamyl transpeptidase)
|
9.1%
4/44 • Number of events 4
|
8.5%
4/47 • Number of events 4
|
|
Blood and lymphatic system disorders
Hemoglobin
|
27.3%
12/44 • Number of events 12
|
51.1%
24/47 • Number of events 24
|
|
Respiratory, thoracic and mediastinal disorders
" Hemorrhage, pulmonary/upper respiratory - Nose"
|
0.00%
0/44
|
6.4%
3/47 • Number of events 3
|
|
Metabolism and nutrition disorders
"Hypercalcemia: Calcium, serum-high (hypercalcemia)"
|
0.00%
0/44
|
8.5%
4/47 • Number of events 4
|
|
Metabolism and nutrition disorders
"Hyperglycemia: Glucose, serum-high (hyperglycemia)"
|
15.9%
7/44 • Number of events 7
|
25.5%
12/47 • Number of events 12
|
|
Metabolism and nutrition disorders
"Hypermagnesemia: Magnesium, serum-high (hypermagnesemia)"
|
0.00%
0/44
|
10.6%
5/47 • Number of events 5
|
|
Vascular disorders
Hypertension
|
0.00%
0/44
|
6.4%
3/47 • Number of events 3
|
|
Metabolism and nutrition disorders
"Hypertriglyceridemia: Triglyceride, serum-high (hypertriglyceridemia)"
|
0.00%
0/44
|
12.8%
6/47 • Number of events 6
|
|
Metabolism and nutrition disorders
"Hypocalcemia: Calcium, serum-low (hypocalcemia)"
|
0.00%
0/44
|
12.8%
6/47 • Number of events 6
|
|
Metabolism and nutrition disorders
"Hypoglycemia: Glucose, serum-low (hypoglycemia)"
|
0.00%
0/44
|
6.4%
3/47 • Number of events 3
|
|
Metabolism and nutrition disorders
"Hypokalemia: Potassium, serum-low (hypokalemia)"
|
9.1%
4/44 • Number of events 4
|
23.4%
11/47 • Number of events 11
|
|
Metabolism and nutrition disorders
"Hypomagnesemia: Magnesium, serum-low (hypomagnesemia)"
|
6.8%
3/44 • Number of events 3
|
10.6%
5/47 • Number of events 5
|
|
Metabolism and nutrition disorders
"Hyponatremia: Sodium, serum-low (hyponatremia)"
|
13.6%
6/44 • Number of events 6
|
29.8%
14/47 • Number of events 14
|
|
Metabolism and nutrition disorders
"Hypophosphatemia: Phosphate, serum-low (hypophosphatemia)"
|
0.00%
0/44
|
17.0%
8/47 • Number of events 8
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Sinus
|
9.1%
4/44 • Number of events 4
|
0.00%
0/47
|
|
Psychiatric disorders
Insomnia
|
13.6%
6/44 • Number of events 6
|
6.4%
3/47 • Number of events 3
|
|
Investigations
Leukocytes (total WBC)
|
38.6%
17/44 • Number of events 17
|
40.4%
19/47 • Number of events 19
|
|
Investigations
Lymphopenia
|
11.4%
5/44 • Number of events 5
|
21.3%
10/47 • Number of events 10
|
|
Psychiatric disorders
Mood alteration - Agitation
|
0.00%
0/44
|
6.4%
3/47 • Number of events 3
|
|
Psychiatric disorders
Mood alteration - Anxiety
|
6.8%
3/44 • Number of events 3
|
0.00%
0/47
|
|
Psychiatric disorders
Mood alteration - Depression
|
6.8%
3/44 • Number of events 3
|
0.00%
0/47
|
|
Gastrointestinal disorders
Nausea
|
29.5%
13/44 • Number of events 13
|
34.0%
16/47 • Number of events 16
|
|
Nervous system disorders
Neuropathy: sensory
|
27.3%
12/44 • Number of events 12
|
21.3%
10/47 • Number of events 10
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
38.6%
17/44 • Number of events 17
|
29.8%
14/47 • Number of events 14
|
|
Gastrointestinal disorders
Pain - Abdomen NOS
|
20.5%
9/44 • Number of events 9
|
23.4%
11/47 • Number of events 11
|
|
Musculoskeletal and connective tissue disorders
Pain - Back
|
6.8%
3/44 • Number of events 3
|
0.00%
0/47
|
|
Musculoskeletal and connective tissue disorders
Pain - Bone
|
0.00%
0/44
|
6.4%
3/47 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Pain - Extremity-limb
|
25.0%
11/44 • Number of events 11
|
23.4%
11/47 • Number of events 11
|
|
Nervous system disorders
Pain - Head/headache
|
15.9%
7/44 • Number of events 7
|
19.1%
9/47 • Number of events 9
|
|
Musculoskeletal and connective tissue disorders
Pain - Joint
|
9.1%
4/44 • Number of events 4
|
6.4%
3/47 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Pain - Muscle
|
0.00%
0/44
|
6.4%
3/47 • Number of events 3
|
|
Gastrointestinal disorders
Pain - Stomach
|
6.8%
3/44 • Number of events 3
|
0.00%
0/47
|
|
Respiratory, thoracic and mediastinal disorders
Pain - Throat/pharynx/larynx
|
6.8%
3/44 • Number of events 3
|
6.4%
3/47 • Number of events 3
|
|
Investigations
Platelets
|
29.5%
13/44 • Number of events 13
|
38.3%
18/47 • Number of events 18
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
0.00%
0/44
|
6.4%
3/47 • Number of events 3
|
|
Gastrointestinal disorders
Vomiting
|
13.6%
6/44 • Number of events 6
|
23.4%
11/47 • Number of events 11
|
|
Investigations
Weight loss
|
9.1%
4/44 • Number of events 4
|
8.5%
4/47 • Number of events 4
|
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
- Publication restrictions are in place