Trial Outcomes & Findings for Pegaspargase and Combination Chemotherapy in Treating Younger Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia (Closed to Accrual 4-22-2011) (NCT NCT00866307)
NCT ID: NCT00866307
Last Updated: 2021-04-27
Results Overview
Percentage of Group B (High Risk-High) patients taking less than 49 weeks from day 1 of consolidation to day 1 of maintenance therapy. Only Group B analyzed since this is prespecified in protocol.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
104 participants
Primary outcome timeframe
Consolidation through Delayed Intensification
Results posted on
2021-04-27
Participant Flow
Patients with newly diagnosed high-risk B-precursor acute lymphoblastic leukemia (ALL), no prior cytotoxic chemotherapy besides steroids and intrathecal cytarabine and WBC criteria: Age 1.00-9.99 years: WBC \>= 50,000/uL; Age 10.00 - 30.99 years or prior steroid therapy or with testicular leukemia: Any WBC
Patients with Day 29 Marrow counts \>25% (M3) or pegaspargase contraindication go off therapy before risk stratification.
Participant milestones
| Measure |
Induction
All Patients
|
Group A (High Risk-Average)
Patients with day 29 MRD \<0.01% and no CNS3, testicular disease, steroid pretreatment, MLL+, or hypodiploidy. Treated with Standard PEG-asparaginase therapy (hABFM)
|
Group B (High Risk-High)
Patients with day 29 MRD \>=0.01% or at least one of: CNS3, Testicular disease, Steroid Pre-treatment, MLL+, or hypodiploidy. Received Intensified PEG-asparaginase therapy
|
|---|---|---|---|
|
Induction
STARTED
|
104
|
0
|
0
|
|
Induction
COMPLETED
|
84
|
0
|
0
|
|
Induction
NOT COMPLETED
|
20
|
0
|
0
|
|
Consolidation/Maintenance
STARTED
|
0
|
54
|
30
|
|
Consolidation/Maintenance
COMPLETED
|
0
|
45
|
14
|
|
Consolidation/Maintenance
NOT COMPLETED
|
0
|
9
|
16
|
Reasons for withdrawal
| Measure |
Induction
All Patients
|
Group A (High Risk-Average)
Patients with day 29 MRD \<0.01% and no CNS3, testicular disease, steroid pretreatment, MLL+, or hypodiploidy. Treated with Standard PEG-asparaginase therapy (hABFM)
|
Group B (High Risk-High)
Patients with day 29 MRD \>=0.01% or at least one of: CNS3, Testicular disease, Steroid Pre-treatment, MLL+, or hypodiploidy. Received Intensified PEG-asparaginase therapy
|
|---|---|---|---|
|
Induction
Adverse Event
|
5
|
0
|
0
|
|
Induction
Death
|
2
|
0
|
0
|
|
Induction
Physician Decision
|
5
|
0
|
0
|
|
Induction
Progressive Disease
|
1
|
0
|
0
|
|
Induction
Identification of Patients with Day 29 M
|
3
|
0
|
0
|
|
Induction
Inadequate cytognetic samples th
|
1
|
0
|
0
|
|
Induction
Improper post-induction consent
|
2
|
0
|
0
|
|
Induction
Study was closed at the time
|
1
|
0
|
0
|
|
Consolidation/Maintenance
Adverse Event
|
0
|
0
|
8
|
|
Consolidation/Maintenance
Death
|
0
|
0
|
1
|
|
Consolidation/Maintenance
Physician Decision
|
0
|
3
|
2
|
|
Consolidation/Maintenance
Withdrawal by Subject
|
0
|
1
|
1
|
|
Consolidation/Maintenance
Development of 2nd malignant neoplasm
|
0
|
0
|
2
|
|
Consolidation/Maintenance
Recurrent leukemia following remission
|
0
|
3
|
1
|
|
Consolidation/Maintenance
Therapy error
|
0
|
1
|
0
|
|
Consolidation/Maintenance
Non-compliance
|
0
|
0
|
1
|
|
Consolidation/Maintenance
Patient moved to non-participating inst
|
0
|
1
|
0
|
Baseline Characteristics
Pegaspargase and Combination Chemotherapy in Treating Younger Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia (Closed to Accrual 4-22-2011)
Baseline characteristics by cohort
| Measure |
Induction
n=104 Participants
All Patients
|
|---|---|
|
Age, Categorical
<=18 years
|
96 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
62 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
37 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
63 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
68 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
21 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Consolidation through Delayed IntensificationPopulation: Patients with High Risk-High (Group B) Acute Lymphoblastic Leukemia (ALL)
Percentage of Group B (High Risk-High) patients taking less than 49 weeks from day 1 of consolidation to day 1 of maintenance therapy. Only Group B analyzed since this is prespecified in protocol.
Outcome measures
| Measure |
Group B (High Risk-High)
n=30 Participants
Patients with day 29 MRD \>=0.01% or at least one of: CNS3, Testicular disease, Steroid Pre-treatment, MLL+, or hypodiploidy. Received Intensified PEG-asparaginase therapy
|
|---|---|
|
AALL08P1 Safety Outcome
|
50.0 percentage of participants
Interval 35.6 to 64.4
|
PRIMARY outcome
Timeframe: Consolidation through Delayed IntensificationPopulation: Patients with High Risk-high Acute Lymphoblastic Leukemia (ALL)
Percentage of Group B (High Risk-High) patients that tolerate at least 8 of the 12-14 total doses of pegaspargase during Consolidation, Interim Maintenance, and Delayed Intensification periods. Only Grp B analyzed since this is prespecified in protocol.
Outcome measures
| Measure |
Group B (High Risk-High)
n=30 Participants
Patients with day 29 MRD \>=0.01% or at least one of: CNS3, Testicular disease, Steroid Pre-treatment, MLL+, or hypodiploidy. Received Intensified PEG-asparaginase therapy
|
|---|---|
|
AALL08P1 Feasibility Outcome
|
53.3 percentage of participants
Interval 38.7 to 67.4
|
Adverse Events
Induction
Serious events: 10 serious events
Other events: 97 other events
Deaths: 0 deaths
Group A (High Risk-Average)
Serious events: 1 serious events
Other events: 53 other events
Deaths: 0 deaths
Group B (High Risk-High)
Serious events: 4 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Induction
n=104 participants at risk
All Patients
|
Group A (High Risk-Average)
n=54 participants at risk
Patients with day 29 MRD \<0.01% and no CNS3, testicular disease, steroid pretreatment, MLL+, or hypodiploidy. Treated with Standard PEG-asparaginase therapy (hABFM).
|
Group B (High Risk-High)
n=30 participants at risk
Patients with day 29 MRD \>=0.01% or at least one of: CNS3, Testicular disease, Steroid Pre-treatment, MLL+, or hypodiploidy. Received Intensified PEG-asparaginase therapy.
|
|---|---|---|---|
|
Investigations
Alanine aminotransferase increased
|
0.96%
1/104 • Number of events 1
|
0.00%
0/54
|
3.3%
1/30 • Number of events 1
|
|
Investigations
Blood bilirubin increased
|
0.96%
1/104 • Number of events 1
|
0.00%
0/54
|
0.00%
0/30
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
0.96%
1/104 • Number of events 1
|
0.00%
0/54
|
0.00%
0/30
|
|
Cardiac disorders
Cardiac arrest
|
0.96%
1/104 • Number of events 1
|
0.00%
0/54
|
0.00%
0/30
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
0.96%
1/104 • Number of events 1
|
0.00%
0/54
|
0.00%
0/30
|
|
Gastrointestinal disorders
Colitis
|
0.96%
1/104 • Number of events 1
|
0.00%
0/54
|
3.3%
1/30 • Number of events 1
|
|
Nervous system disorders
Depressed level of consciousness
|
0.96%
1/104 • Number of events 1
|
0.00%
0/54
|
0.00%
0/30
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.96%
1/104 • Number of events 1
|
0.00%
0/54
|
0.00%
0/30
|
|
Nervous system disorders
Dysphasia
|
0.96%
1/104 • Number of events 1
|
1.9%
1/54 • Number of events 1
|
0.00%
0/30
|
|
Investigations
Fibrinogen decreased
|
0.96%
1/104 • Number of events 1
|
0.00%
0/54
|
3.3%
1/30 • Number of events 1
|
|
Hepatobiliary disorders
Hepatic hemorrhage
|
0.96%
1/104 • Number of events 1
|
0.00%
0/54
|
0.00%
0/30
|
|
Vascular disorders
Hypertension
|
0.96%
1/104 • Number of events 1
|
0.00%
0/54
|
0.00%
0/30
|
|
Vascular disorders
Hypotension
|
2.9%
3/104 • Number of events 3
|
0.00%
0/54
|
6.7%
2/30 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.96%
1/104 • Number of events 1
|
0.00%
0/54
|
3.3%
1/30 • Number of events 1
|
|
Infections and infestations
Infections and infestations - Other, specify
|
3.8%
4/104 • Number of events 4
|
0.00%
0/54
|
6.7%
2/30 • Number of events 2
|
|
Nervous system disorders
Intracranial hemorrhage
|
1.9%
2/104 • Number of events 2
|
0.00%
0/54
|
6.7%
2/30 • Number of events 2
|
|
Investigations
Investigations - Other, specify
|
0.96%
1/104 • Number of events 1
|
0.00%
0/54
|
3.3%
1/30 • Number of events 1
|
|
General disorders
Multi-organ failure
|
0.96%
1/104 • Number of events 1
|
0.00%
0/54
|
3.3%
1/30 • Number of events 1
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
3.8%
4/104 • Number of events 6
|
1.9%
1/54 • Number of events 1
|
0.00%
0/30
|
|
Investigations
Platelet count decreased
|
0.96%
1/104 • Number of events 1
|
0.00%
0/54
|
3.3%
1/30 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.96%
1/104 • Number of events 1
|
0.00%
0/54
|
0.00%
0/30
|
|
Nervous system disorders
Seizure
|
3.8%
4/104 • Number of events 4
|
1.9%
1/54 • Number of events 1
|
3.3%
1/30 • Number of events 1
|
|
Nervous system disorders
Syncope
|
0.96%
1/104 • Number of events 1
|
0.00%
0/54
|
3.3%
1/30 • Number of events 1
|
|
Vascular disorders
Thromboembolic event
|
1.9%
2/104 • Number of events 2
|
0.00%
0/54
|
3.3%
1/30 • Number of events 1
|
|
Gastrointestinal disorders
Typhlitis
|
0.96%
1/104 • Number of events 1
|
0.00%
0/54
|
3.3%
1/30 • Number of events 1
|
Other adverse events
| Measure |
Induction
n=104 participants at risk
All Patients
|
Group A (High Risk-Average)
n=54 participants at risk
Patients with day 29 MRD \<0.01% and no CNS3, testicular disease, steroid pretreatment, MLL+, or hypodiploidy. Treated with Standard PEG-asparaginase therapy (hABFM).
|
Group B (High Risk-High)
n=30 participants at risk
Patients with day 29 MRD \>=0.01% or at least one of: CNS3, Testicular disease, Steroid Pre-treatment, MLL+, or hypodiploidy. Received Intensified PEG-asparaginase therapy.
|
|---|---|---|---|
|
Infections and infestations
Abdominal infection
|
1.9%
2/104 • Number of events 2
|
3.7%
2/54 • Number of events 2
|
0.00%
0/30
|
|
Gastrointestinal disorders
Abdominal pain
|
10.6%
11/104 • Number of events 12
|
14.8%
8/54 • Number of events 9
|
10.0%
3/30 • Number of events 3
|
|
Nervous system disorders
Abducens nerve disorder
|
0.96%
1/104 • Number of events 1
|
1.9%
1/54 • Number of events 1
|
0.00%
0/30
|
|
Investigations
Activated partial thromboplastin time prolonged
|
1.9%
2/104 • Number of events 3
|
3.7%
2/54 • Number of events 3
|
0.00%
0/30
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
0.96%
1/104 • Number of events 1
|
0.00%
0/54
|
0.00%
0/30
|
|
Psychiatric disorders
Agitation
|
3.8%
4/104 • Number of events 4
|
3.7%
2/54 • Number of events 2
|
0.00%
0/30
|
|
Investigations
Alanine aminotransferase increased
|
45.2%
47/104 • Number of events 100
|
51.9%
28/54 • Number of events 70
|
50.0%
15/30 • Number of events 25
|
|
Investigations
Alkaline phosphatase increased
|
3.8%
4/104 • Number of events 4
|
5.6%
3/54 • Number of events 3
|
3.3%
1/30 • Number of events 1
|
|
Immune system disorders
Allergic reaction
|
9.6%
10/104 • Number of events 11
|
13.0%
7/54 • Number of events 8
|
10.0%
3/30 • Number of events 3
|
|
Immune system disorders
Anaphylaxis
|
14.4%
15/104 • Number of events 17
|
16.7%
9/54 • Number of events 11
|
16.7%
5/30 • Number of events 5
|
|
Blood and lymphatic system disorders
Anemia
|
30.8%
32/104 • Number of events 58
|
33.3%
18/54 • Number of events 35
|
36.7%
11/30 • Number of events 19
|
|
Infections and infestations
Anorectal infection
|
1.9%
2/104 • Number of events 2
|
3.7%
2/54 • Number of events 2
|
0.00%
0/30
|
|
Metabolism and nutrition disorders
Anorexia
|
6.7%
7/104 • Number of events 8
|
5.6%
3/54 • Number of events 4
|
10.0%
3/30 • Number of events 3
|
|
Psychiatric disorders
Anxiety
|
1.9%
2/104 • Number of events 3
|
3.7%
2/54 • Number of events 3
|
0.00%
0/30
|
|
Infections and infestations
Appendicitis perforated
|
0.96%
1/104 • Number of events 1
|
1.9%
1/54 • Number of events 1
|
0.00%
0/30
|
|
Nervous system disorders
Arachnoiditis
|
0.96%
1/104 • Number of events 1
|
1.9%
1/54 • Number of events 1
|
0.00%
0/30
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.9%
2/104 • Number of events 2
|
1.9%
1/54 • Number of events 1
|
3.3%
1/30 • Number of events 1
|
|
Gastrointestinal disorders
Ascites
|
0.96%
1/104 • Number of events 1
|
1.9%
1/54 • Number of events 1
|
0.00%
0/30
|
|
Investigations
Aspartate aminotransferase increased
|
22.1%
23/104 • Number of events 30
|
25.9%
14/54 • Number of events 20
|
23.3%
7/30 • Number of events 8
|
|
Nervous system disorders
Ataxia
|
1.9%
2/104 • Number of events 3
|
3.7%
2/54 • Number of events 3
|
0.00%
0/30
|
|
Musculoskeletal and connective tissue disorders
Avascular necrosis
|
8.7%
9/104 • Number of events 22
|
13.0%
7/54 • Number of events 19
|
6.7%
2/30 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.9%
3/104 • Number of events 3
|
3.7%
2/54 • Number of events 2
|
3.3%
1/30 • Number of events 1
|
|
Infections and infestations
Bladder infection
|
0.96%
1/104 • Number of events 1
|
1.9%
1/54 • Number of events 1
|
0.00%
0/30
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
0.96%
1/104 • Number of events 1
|
0.00%
0/54
|
0.00%
0/30
|
|
Investigations
Blood bilirubin increased
|
18.3%
19/104 • Number of events 29
|
18.5%
10/54 • Number of events 15
|
20.0%
6/30 • Number of events 11
|
|
Infections and infestations
Bronchial infection
|
0.96%
1/104 • Number of events 1
|
1.9%
1/54 • Number of events 1
|
0.00%
0/30
|
|
Infections and infestations
Catheter related infection
|
3.8%
4/104 • Number of events 4
|
3.7%
2/54 • Number of events 2
|
6.7%
2/30 • Number of events 2
|
|
Nervous system disorders
Cerebrospinal fluid leakage
|
0.96%
1/104 • Number of events 1
|
1.9%
1/54 • Number of events 1
|
0.00%
0/30
|
|
Investigations
Cholesterol high
|
0.96%
1/104 • Number of events 1
|
1.9%
1/54 • Number of events 1
|
0.00%
0/30
|
|
Nervous system disorders
Cognitive disturbance
|
0.96%
1/104 • Number of events 1
|
1.9%
1/54 • Number of events 1
|
0.00%
0/30
|
|
Gastrointestinal disorders
Colitis
|
0.96%
1/104 • Number of events 1
|
0.00%
0/54
|
3.3%
1/30 • Number of events 1
|
|
Nervous system disorders
Concentration impairment
|
0.96%
1/104 • Number of events 1
|
1.9%
1/54 • Number of events 1
|
0.00%
0/30
|
|
Psychiatric disorders
Confusion
|
1.9%
2/104 • Number of events 2
|
1.9%
1/54 • Number of events 1
|
0.00%
0/30
|
|
Gastrointestinal disorders
Constipation
|
1.9%
2/104 • Number of events 2
|
1.9%
1/54 • Number of events 1
|
3.3%
1/30 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.96%
1/104 • Number of events 1
|
1.9%
1/54 • Number of events 1
|
0.00%
0/30
|
|
Investigations
Creatinine increased
|
1.9%
2/104 • Number of events 2
|
1.9%
1/54 • Number of events 1
|
3.3%
1/30 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
3.8%
4/104 • Number of events 4
|
5.6%
3/54 • Number of events 3
|
3.3%
1/30 • Number of events 1
|
|
Nervous system disorders
Depressed level of consciousness
|
1.9%
2/104 • Number of events 2
|
1.9%
1/54 • Number of events 1
|
3.3%
1/30 • Number of events 1
|
|
Psychiatric disorders
Depression
|
0.96%
1/104 • Number of events 1
|
1.9%
1/54 • Number of events 1
|
0.00%
0/30
|
|
Gastrointestinal disorders
Diarrhea
|
2.9%
3/104 • Number of events 3
|
3.7%
2/54 • Number of events 2
|
3.3%
1/30 • Number of events 1
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.96%
1/104 • Number of events 1
|
0.00%
0/54
|
3.3%
1/30 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
0.96%
1/104 • Number of events 1
|
1.9%
1/54 • Number of events 1
|
0.00%
0/30
|
|
Gastrointestinal disorders
Dysphagia
|
0.96%
1/104 • Number of events 1
|
0.00%
0/54
|
3.3%
1/30 • Number of events 1
|
|
Nervous system disorders
Dysphasia
|
1.9%
2/104 • Number of events 2
|
3.7%
2/54 • Number of events 2
|
0.00%
0/30
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.96%
1/104 • Number of events 1
|
0.00%
0/54
|
0.00%
0/30
|
|
Nervous system disorders
Encephalopathy
|
1.9%
2/104 • Number of events 2
|
1.9%
1/54 • Number of events 1
|
0.00%
0/30
|
|
Infections and infestations
Enterocolitis infectious
|
5.8%
6/104 • Number of events 8
|
11.1%
6/54 • Number of events 8
|
0.00%
0/30
|
|
Infections and infestations
Esophageal infection
|
0.96%
1/104 • Number of events 1
|
0.00%
0/54
|
3.3%
1/30 • Number of events 1
|
|
General disorders
Fatigue
|
1.9%
2/104 • Number of events 2
|
1.9%
1/54 • Number of events 1
|
3.3%
1/30 • Number of events 1
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
54.8%
57/104 • Number of events 130
|
70.4%
38/54 • Number of events 85
|
60.0%
18/30 • Number of events 44
|
|
General disorders
Fever
|
4.8%
5/104 • Number of events 5
|
7.4%
4/54 • Number of events 4
|
0.00%
0/30
|
|
Investigations
Fibrinogen decreased
|
10.6%
11/104 • Number of events 15
|
13.0%
7/54 • Number of events 11
|
10.0%
3/30 • Number of events 3
|
|
General disorders
Gait disturbance
|
0.96%
1/104 • Number of events 1
|
0.00%
0/54
|
3.3%
1/30 • Number of events 1
|
|
Investigations
GGT increased
|
8.7%
9/104 • Number of events 9
|
1.9%
1/54 • Number of events 1
|
20.0%
6/30 • Number of events 6
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
4.8%
5/104 • Number of events 6
|
7.4%
4/54 • Number of events 5
|
3.3%
1/30 • Number of events 1
|
|
Psychiatric disorders
Hallucinations
|
0.96%
1/104 • Number of events 1
|
0.00%
0/54
|
3.3%
1/30 • Number of events 1
|
|
Nervous system disorders
Headache
|
3.8%
4/104 • Number of events 5
|
5.6%
3/54 • Number of events 4
|
3.3%
1/30 • Number of events 1
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
1.9%
2/104 • Number of events 2
|
1.9%
1/54 • Number of events 1
|
3.3%
1/30 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.96%
1/104 • Number of events 2
|
1.9%
1/54 • Number of events 2
|
0.00%
0/30
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
23.1%
24/104 • Number of events 31
|
22.2%
12/54 • Number of events 18
|
26.7%
8/30 • Number of events 9
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
7.7%
8/104 • Number of events 8
|
7.4%
4/54 • Number of events 4
|
10.0%
3/30 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.96%
1/104 • Number of events 1
|
1.9%
1/54 • Number of events 1
|
0.00%
0/30
|
|
Vascular disorders
Hypertension
|
6.7%
7/104 • Number of events 7
|
3.7%
2/54 • Number of events 2
|
13.3%
4/30 • Number of events 4
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
2.9%
3/104 • Number of events 3
|
5.6%
3/54 • Number of events 3
|
0.00%
0/30
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
1.9%
2/104 • Number of events 2
|
1.9%
1/54 • Number of events 1
|
3.3%
1/30 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
8.7%
9/104 • Number of events 12
|
5.6%
3/54 • Number of events 3
|
10.0%
3/30 • Number of events 6
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
10.6%
11/104 • Number of events 12
|
13.0%
7/54 • Number of events 8
|
10.0%
3/30 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypokalemia
|
11.5%
12/104 • Number of events 16
|
11.1%
6/54 • Number of events 8
|
13.3%
4/30 • Number of events 6
|
|
Metabolism and nutrition disorders
Hyponatremia
|
19.2%
20/104 • Number of events 24
|
18.5%
10/54 • Number of events 13
|
23.3%
7/30 • Number of events 7
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
6.7%
7/104 • Number of events 7
|
1.9%
1/54 • Number of events 1
|
13.3%
4/30 • Number of events 4
|
|
Vascular disorders
Hypotension
|
2.9%
3/104 • Number of events 3
|
3.7%
2/54 • Number of events 2
|
3.3%
1/30 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
4.8%
5/104 • Number of events 5
|
5.6%
3/54 • Number of events 3
|
0.00%
0/30
|
|
Immune system disorders
Immune system disorders - Other, specify
|
3.8%
4/104 • Number of events 8
|
5.6%
3/54 • Number of events 7
|
3.3%
1/30 • Number of events 1
|
|
Infections and infestations
Infections and infestations - Other, specify
|
59.6%
62/104 • Number of events 155
|
72.2%
39/54 • Number of events 98
|
56.7%
17/30 • Number of events 39
|
|
Infections and infestations
Infective myositis
|
0.96%
1/104 • Number of events 2
|
1.9%
1/54 • Number of events 2
|
0.00%
0/30
|
|
Investigations
INR increased
|
0.96%
1/104 • Number of events 1
|
0.00%
0/54
|
3.3%
1/30 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
0.96%
1/104 • Number of events 1
|
1.9%
1/54 • Number of events 1
|
0.00%
0/30
|
|
Injury, poisoning and procedural complications
Intraoperative gastrointestinal injury
|
0.96%
1/104 • Number of events 1
|
1.9%
1/54 • Number of events 1
|
0.00%
0/30
|
|
Investigations
Investigations - Other, specify
|
0.96%
1/104 • Number of events 1
|
0.00%
0/54
|
3.3%
1/30 • Number of events 1
|
|
Metabolism and nutrition disorders
Iron overload
|
0.96%
1/104 • Number of events 1
|
1.9%
1/54 • Number of events 1
|
0.00%
0/30
|
|
Nervous system disorders
Ischemia cerebrovascular
|
1.9%
2/104 • Number of events 2
|
0.00%
0/54
|
6.7%
2/30 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.96%
1/104 • Number of events 2
|
1.9%
1/54 • Number of events 2
|
0.00%
0/30
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.96%
1/104 • Number of events 1
|
1.9%
1/54 • Number of events 1
|
0.00%
0/30
|
|
Infections and infestations
Kidney infection
|
0.96%
1/104 • Number of events 1
|
1.9%
1/54 • Number of events 1
|
0.00%
0/30
|
|
Nervous system disorders
Leukoencephalopathy
|
3.8%
4/104 • Number of events 4
|
5.6%
3/54 • Number of events 3
|
3.3%
1/30 • Number of events 1
|
|
Investigations
Lipase increased
|
9.6%
10/104 • Number of events 13
|
9.3%
5/54 • Number of events 8
|
10.0%
3/30 • Number of events 3
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
0.96%
1/104 • Number of events 1
|
0.00%
0/54
|
0.00%
0/30
|
|
Infections and infestations
Lung infection
|
9.6%
10/104 • Number of events 16
|
13.0%
7/54 • Number of events 11
|
10.0%
3/30 • Number of events 5
|
|
Infections and infestations
Lymph gland infection
|
0.96%
1/104 • Number of events 1
|
1.9%
1/54 • Number of events 1
|
0.00%
0/30
|
|
Investigations
Lymphocyte count decreased
|
1.9%
2/104 • Number of events 4
|
3.7%
2/54 • Number of events 4
|
0.00%
0/30
|
|
Gastrointestinal disorders
Malabsorption
|
1.9%
2/104 • Number of events 2
|
3.7%
2/54 • Number of events 2
|
0.00%
0/30
|
|
Infections and infestations
Mucosal infection
|
0.96%
1/104 • Number of events 1
|
1.9%
1/54 • Number of events 1
|
0.00%
0/30
|
|
Gastrointestinal disorders
Mucositis oral
|
9.6%
10/104 • Number of events 10
|
11.1%
6/54 • Number of events 6
|
13.3%
4/30 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
2.9%
3/104 • Number of events 7
|
1.9%
1/54 • Number of events 4
|
3.3%
1/30 • Number of events 1
|
|
Infections and infestations
Nail infection
|
0.96%
1/104 • Number of events 1
|
1.9%
1/54 • Number of events 1
|
0.00%
0/30
|
|
Gastrointestinal disorders
Nausea
|
2.9%
3/104 • Number of events 3
|
3.7%
2/54 • Number of events 2
|
0.00%
0/30
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.96%
1/104 • Number of events 1
|
1.9%
1/54 • Number of events 1
|
0.00%
0/30
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
0.96%
1/104 • Number of events 1
|
1.9%
1/54 • Number of events 1
|
0.00%
0/30
|
|
Nervous system disorders
Neuralgia
|
1.9%
2/104 • Number of events 4
|
1.9%
1/54 • Number of events 2
|
3.3%
1/30 • Number of events 2
|
|
Investigations
Neutrophil count decreased
|
69.2%
72/104 • Number of events 212
|
87.0%
47/54 • Number of events 144
|
70.0%
21/30 • Number of events 61
|
|
Metabolism and nutrition disorders
Obesity
|
1.9%
2/104 • Number of events 2
|
3.7%
2/54 • Number of events 2
|
0.00%
0/30
|
|
Nervous system disorders
Oculomotor nerve disorder
|
1.9%
2/104 • Number of events 3
|
1.9%
1/54 • Number of events 2
|
3.3%
1/30 • Number of events 1
|
|
Eye disorders
Optic nerve disorder
|
0.96%
1/104 • Number of events 1
|
1.9%
1/54 • Number of events 1
|
0.00%
0/30
|
|
Gastrointestinal disorders
Oral pain
|
2.9%
3/104 • Number of events 3
|
3.7%
2/54 • Number of events 2
|
3.3%
1/30 • Number of events 1
|
|
Infections and infestations
Otitis media
|
1.9%
2/104 • Number of events 2
|
3.7%
2/54 • Number of events 2
|
0.00%
0/30
|
|
General disorders
Pain
|
3.8%
4/104 • Number of events 4
|
3.7%
2/54 • Number of events 2
|
6.7%
2/30 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.7%
9/104 • Number of events 13
|
9.3%
5/54 • Number of events 6
|
10.0%
3/30 • Number of events 3
|
|
Investigations
Pancreatic enzymes decreased
|
0.96%
1/104 • Number of events 1
|
1.9%
1/54 • Number of events 1
|
0.00%
0/30
|
|
Gastrointestinal disorders
Pancreatic necrosis
|
0.96%
1/104 • Number of events 2
|
1.9%
1/54 • Number of events 2
|
0.00%
0/30
|
|
Gastrointestinal disorders
Pancreatitis
|
6.7%
7/104 • Number of events 9
|
7.4%
4/54 • Number of events 6
|
6.7%
2/30 • Number of events 2
|
|
Eye disorders
Papilledema
|
0.96%
1/104 • Number of events 1
|
0.00%
0/54
|
3.3%
1/30 • Number of events 1
|
|
Nervous system disorders
Peripheral motor neuropathy
|
19.2%
20/104 • Number of events 30
|
18.5%
10/54 • Number of events 13
|
30.0%
9/30 • Number of events 16
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
21.2%
22/104 • Number of events 31
|
24.1%
13/54 • Number of events 16
|
23.3%
7/30 • Number of events 12
|
|
Psychiatric disorders
Personality change
|
2.9%
3/104 • Number of events 4
|
3.7%
2/54 • Number of events 2
|
3.3%
1/30 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mucositis
|
0.96%
1/104 • Number of events 1
|
1.9%
1/54 • Number of events 1
|
0.00%
0/30
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.96%
1/104 • Number of events 1
|
0.00%
0/54
|
3.3%
1/30 • Number of events 1
|
|
Investigations
Platelet count decreased
|
32.7%
34/104 • Number of events 70
|
37.0%
20/54 • Number of events 37
|
36.7%
11/30 • Number of events 22
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.8%
4/104 • Number of events 5
|
3.7%
2/54 • Number of events 2
|
6.7%
2/30 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.9%
2/104 • Number of events 2
|
3.7%
2/54 • Number of events 2
|
0.00%
0/30
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.96%
1/104 • Number of events 1
|
0.00%
0/54
|
0.00%
0/30
|
|
Psychiatric disorders
Psychosis
|
0.96%
1/104 • Number of events 1
|
1.9%
1/54 • Number of events 1
|
0.00%
0/30
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
0.96%
1/104 • Number of events 2
|
0.00%
0/54
|
0.00%
0/30
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
0.96%
1/104 • Number of events 1
|
0.00%
0/54
|
0.00%
0/30
|
|
Nervous system disorders
Seizure
|
4.8%
5/104 • Number of events 5
|
7.4%
4/54 • Number of events 4
|
3.3%
1/30 • Number of events 1
|
|
Infections and infestations
Sepsis
|
1.9%
2/104 • Number of events 2
|
0.00%
0/54
|
3.3%
1/30 • Number of events 1
|
|
Investigations
Serum amylase increased
|
4.8%
5/104 • Number of events 6
|
5.6%
3/54 • Number of events 4
|
3.3%
1/30 • Number of events 1
|
|
Infections and infestations
Sinusitis
|
3.8%
4/104 • Number of events 4
|
7.4%
4/54 • Number of events 4
|
0.00%
0/30
|
|
Infections and infestations
Skin infection
|
4.8%
5/104 • Number of events 6
|
3.7%
2/54 • Number of events 2
|
6.7%
2/30 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.96%
1/104 • Number of events 1
|
1.9%
1/54 • Number of events 1
|
0.00%
0/30
|
|
Musculoskeletal and connective tissue disorders
Soft tissue necrosis lower limb
|
0.96%
1/104 • Number of events 1
|
0.00%
0/54
|
0.00%
0/30
|
|
Musculoskeletal and connective tissue disorders
Soft tissue necrosis upper limb
|
0.96%
1/104 • Number of events 1
|
0.00%
0/54
|
0.00%
0/30
|
|
Psychiatric disorders
Suicidal ideation
|
0.96%
1/104 • Number of events 1
|
1.9%
1/54 • Number of events 1
|
0.00%
0/30
|
|
Nervous system disorders
Syncope
|
1.9%
2/104 • Number of events 2
|
1.9%
1/54 • Number of events 1
|
3.3%
1/30 • Number of events 1
|
|
Vascular disorders
Thromboembolic event
|
2.9%
3/104 • Number of events 3
|
5.6%
3/54 • Number of events 3
|
0.00%
0/30
|
|
Gastrointestinal disorders
Toothache
|
0.96%
1/104 • Number of events 1
|
1.9%
1/54 • Number of events 1
|
0.00%
0/30
|
|
Nervous system disorders
Tremor
|
0.96%
1/104 • Number of events 1
|
1.9%
1/54 • Number of events 1
|
0.00%
0/30
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
0.96%
1/104 • Number of events 1
|
1.9%
1/54 • Number of events 1
|
0.00%
0/30
|
|
Gastrointestinal disorders
Typhlitis
|
2.9%
3/104 • Number of events 3
|
5.6%
3/54 • Number of events 3
|
0.00%
0/30
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.96%
1/104 • Number of events 1
|
0.00%
0/54
|
0.00%
0/30
|
|
Infections and infestations
Upper respiratory infection
|
5.8%
6/104 • Number of events 7
|
5.6%
3/54 • Number of events 4
|
10.0%
3/30 • Number of events 3
|
|
Infections and infestations
Urinary tract infection
|
3.8%
4/104 • Number of events 9
|
5.6%
3/54 • Number of events 4
|
3.3%
1/30 • Number of events 5
|
|
Renal and urinary disorders
Urinary tract pain
|
0.96%
1/104 • Number of events 1
|
0.00%
0/54
|
3.3%
1/30 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.96%
1/104 • Number of events 1
|
1.9%
1/54 • Number of events 1
|
0.00%
0/30
|
|
Reproductive system and breast disorders
Uterine hemorrhage
|
0.96%
1/104 • Number of events 1
|
1.9%
1/54 • Number of events 1
|
0.00%
0/30
|
|
Infections and infestations
Vaginal infection
|
0.96%
1/104 • Number of events 1
|
1.9%
1/54 • Number of events 1
|
0.00%
0/30
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
7.7%
8/104 • Number of events 11
|
11.1%
6/54 • Number of events 9
|
3.3%
1/30 • Number of events 1
|
|
Vascular disorders
Vascular disorders - Other, specify
|
1.9%
2/104 • Number of events 2
|
0.00%
0/54
|
0.00%
0/30
|
|
Gastrointestinal disorders
Vomiting
|
3.8%
4/104 • Number of events 4
|
7.4%
4/54 • Number of events 4
|
0.00%
0/30
|
|
Investigations
Weight gain
|
0.96%
1/104 • Number of events 1
|
0.00%
0/54
|
3.3%
1/30 • Number of events 1
|
|
Investigations
Weight loss
|
5.8%
6/104 • Number of events 8
|
7.4%
4/54 • Number of events 5
|
6.7%
2/30 • Number of events 3
|
|
Investigations
White blood cell decreased
|
35.6%
37/104 • Number of events 102
|
40.7%
22/54 • Number of events 64
|
40.0%
12/30 • Number of events 33
|
|
Cardiac disorders
Wolff-Parkinson-White syndrome
|
0.96%
1/104 • Number of events 1
|
1.9%
1/54 • Number of events 1
|
0.00%
0/30
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.96%
1/104 • Number of events 1
|
0.00%
0/54
|
0.00%
0/30
|
|
Infections and infestations
Wound infection
|
0.96%
1/104 • Number of events 4
|
0.00%
0/54
|
0.00%
0/30
|
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