Trial Outcomes & Findings for Clinical Study of Vorinostat in Combination With Etoposide in Pediatric Patients < 21 Years at Diagnosis With Refractory Solid Tumors (NCT NCT01294670)
NCT ID: NCT01294670
Last Updated: 2021-11-18
Results Overview
of the novel combination vorinostat and etoposide in pediatric patients with refractory solid tumors including tumors of the central nervous system. The Toxicity will be evaluated according to NCI CTCAE Version 4.0.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
27 participants
Primary outcome timeframe
Patients will be assessed in 3-week cycles.
Results posted on
2021-11-18
Participant Flow
Participant milestones
| Measure |
Dose Level 1
100 mg/m2 Etoposide, 125 mg/m2 Vorinostat + Data Migration
|
Dose Level 2
100 mg/m2 Etoposide, 160 mg/m2 Vorinostat + Data Migration
|
Dose Level 3
100 mg/m2 Etoposide, 210 mg/m2 Vorinostat + Data Migration
|
Dose Level 4
100 mg/m2 Etoposide, 270 mg/m2 Vorinostat + Data Migration
|
Phase II
Vorinostat 270 mg/m2; Etoposide 100 mg/m2 + Data Migration
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
3
|
3
|
9
|
5
|
|
Overall Study
COMPLETED
|
6
|
3
|
3
|
9
|
5
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Dose Level 1
100 mg/m2 Etoposide, 125 mg/m2 Vorinostat + Data Migration
|
Dose Level 2
100 mg/m2 Etoposide, 160 mg/m2 Vorinostat + Data Migration
|
Dose Level 3
100 mg/m2 Etoposide, 210 mg/m2 Vorinostat + Data Migration
|
Dose Level 4
100 mg/m2 Etoposide, 270 mg/m2 Vorinostat + Data Migration
|
Phase II
Vorinostat 270 mg/m2; Etoposide 100 mg/m2 + Data Migration
|
|---|---|---|---|---|---|
|
Overall Study
Not treated
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Clinical Study of Vorinostat in Combination With Etoposide in Pediatric Patients < 21 Years at Diagnosis With Refractory Solid Tumors
Baseline characteristics by cohort
| Measure |
Dose Level 1
n=7 Participants
100 mg/m2 Etoposide, 125 mg/m2 Vorinostat + Data Migration
|
Dose Level 2
n=3 Participants
100 mg/m2 Etoposide, 160 mg/m2 Vorinostat + Data Migration
|
Dose Level 3
n=3 Participants
100 mg/m2 Etoposide, 210 mg/m2 Vorinostat + Data Migration
|
Dose Level 4
n=9 Participants
100 mg/m2 Etoposide, 270 mg/m2 Vorinostat + Data Migration
|
Phase II Dose
n=5 Participants
Vorinostat 270 mg/m2; Etoposide 100 mg/m2 + Data Migration
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
11 years
n=93 Participants
|
12 years
n=4 Participants
|
11.7 years
n=27 Participants
|
10.2 years
n=483 Participants
|
13.6 years
n=36 Participants
|
13 years
n=10 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
14 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
13 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
4 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
8 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
23 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
5 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
8 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
20 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
7 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
9 Participants
n=483 Participants
|
5 Participants
n=36 Participants
|
27 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Patients will be assessed in 3-week cycles.Population: Data were not collected
of the novel combination vorinostat and etoposide in pediatric patients with refractory solid tumors including tumors of the central nervous system. The Toxicity will be evaluated according to NCI CTCAE Version 4.0.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 1 yearPopulation: Data were not collected
of the novel combination vorinostat and etoposide in pediatric patients with refractory solid tumors including tumors of the central nervous system.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 1 yearPopulation: Data were not collected
of the novel combination vorinostat and etoposide in pediatric patients with relapsed/refractory sarcoma. Evaluation for response will be determined by Revised RECIST guideline
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearPopulation: Data were not collected
of the novel combination vorinostat and etoposide in pediatric patients enrolled in the phase I component of the study. Evaluation for response will be determined by Revised RECIST guideline.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsPopulation: Data were not collected
of the novel combination of vorinostat and etoposide in pediatric patients with refractory solid tumors including central nervous system tumors
Outcome measures
Outcome data not reported
Adverse Events
Dose Level 1
Serious events: 3 serious events
Other events: 7 other events
Deaths: 5 deaths
Dose Level 2
Serious events: 3 serious events
Other events: 3 other events
Deaths: 2 deaths
Dose Level 3
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
Dose Level 4
Serious events: 3 serious events
Other events: 9 other events
Deaths: 4 deaths
Phase II Dose
Serious events: 4 serious events
Other events: 5 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Dose Level 1
n=7 participants at risk
100 mg/m2 Etoposide, 125 mg/m2 Vorinostat (n=7)
|
Dose Level 2
n=3 participants at risk
100 mg/m2 Etoposide, 160 mg/m2 Vorinostat (n=3)
|
Dose Level 3
n=3 participants at risk
100 mg/m2 Etoposide, 210 mg/m2 Vorinostat (n=3)
|
Dose Level 4
n=9 participants at risk
100 mg/m2 Etoposide, 270 mg/m2 Vorinostat (n=9)
|
Phase II Dose
n=5 participants at risk
Vorinostat 270 mg/m2; Etoposide 100 mg/m2 (n=5)
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
14.3%
1/7 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/9 • 1 year
|
20.0%
1/5 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/7 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/9 • 1 year
|
20.0%
1/5 • 1 year
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/7 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/9 • 1 year
|
0.00%
0/5 • 1 year
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/7 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/9 • 1 year
|
20.0%
1/5 • 1 year
|
|
General disorders
Death NOS
|
14.3%
1/7 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/9 • 1 year
|
0.00%
0/5 • 1 year
|
|
General disorders
Fever
|
14.3%
1/7 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/9 • 1 year
|
0.00%
0/5 • 1 year
|
|
Nervous system disorders
Headache
|
0.00%
0/7 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/9 • 1 year
|
0.00%
0/5 • 1 year
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
14.3%
1/7 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/9 • 1 year
|
0.00%
0/5 • 1 year
|
|
Metabolism and nutrition disorders
Hypernatremia
|
14.3%
1/7 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/9 • 1 year
|
0.00%
0/5 • 1 year
|
|
Infections and infestations
Infections and infestations - Other, specify
|
0.00%
0/7 • 1 year
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/9 • 1 year
|
0.00%
0/5 • 1 year
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/7 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/9 • 1 year
|
20.0%
1/5 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/7 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/9 • 1 year
|
0.00%
0/5 • 1 year
|
|
Investigations
Neutrophil count decreased
|
28.6%
2/7 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
22.2%
2/9 • 1 year
|
40.0%
2/5 • 1 year
|
|
Investigations
Platelet count decreased
|
28.6%
2/7 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
11.1%
1/9 • 1 year
|
20.0%
1/5 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/7 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
11.1%
1/9 • 1 year
|
0.00%
0/5 • 1 year
|
|
Infections and infestations
Sepsis
|
14.3%
1/7 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/9 • 1 year
|
20.0%
1/5 • 1 year
|
|
Cardiac disorders
Sinus tachycardia
|
14.3%
1/7 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/9 • 1 year
|
0.00%
0/5 • 1 year
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/7 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/9 • 1 year
|
20.0%
1/5 • 1 year
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
1/7 • 1 year
|
33.3%
1/3 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/9 • 1 year
|
0.00%
0/5 • 1 year
|
|
Investigations
White blood cell decreased
|
0.00%
0/7 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
11.1%
1/9 • 1 year
|
20.0%
1/5 • 1 year
|
Other adverse events
| Measure |
Dose Level 1
n=7 participants at risk
100 mg/m2 Etoposide, 125 mg/m2 Vorinostat (n=7)
|
Dose Level 2
n=3 participants at risk
100 mg/m2 Etoposide, 160 mg/m2 Vorinostat (n=3)
|
Dose Level 3
n=3 participants at risk
100 mg/m2 Etoposide, 210 mg/m2 Vorinostat (n=3)
|
Dose Level 4
n=9 participants at risk
100 mg/m2 Etoposide, 270 mg/m2 Vorinostat (n=9)
|
Phase II Dose
n=5 participants at risk
Vorinostat 270 mg/m2; Etoposide 100 mg/m2 (n=5)
|
|---|---|---|---|---|---|
|
Investigations
White blood cell decreased
|
100.0%
7/7 • 1 year
|
33.3%
1/3 • 1 year
|
66.7%
2/3 • 1 year
|
55.6%
5/9 • 1 year
|
60.0%
3/5 • 1 year
|
|
Investigations
Neutrophil count decreased
|
100.0%
7/7 • 1 year
|
0.00%
0/3 • 1 year
|
100.0%
3/3 • 1 year
|
66.7%
6/9 • 1 year
|
60.0%
3/5 • 1 year
|
|
Investigations
Platelet count decreased
|
85.7%
6/7 • 1 year
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • 1 year
|
44.4%
4/9 • 1 year
|
40.0%
2/5 • 1 year
|
|
Blood and lymphatic system disorders
Anemia
|
71.4%
5/7 • 1 year
|
0.00%
0/3 • 1 year
|
66.7%
2/3 • 1 year
|
22.2%
2/9 • 1 year
|
60.0%
3/5 • 1 year
|
|
General disorders
Fatigue
|
14.3%
1/7 • 1 year
|
33.3%
1/3 • 1 year
|
33.3%
1/3 • 1 year
|
22.2%
2/9 • 1 year
|
20.0%
1/5 • 1 year
|
|
Investigations
Lymphocyte count decreased
|
71.4%
5/7 • 1 year
|
33.3%
1/3 • 1 year
|
66.7%
2/3 • 1 year
|
55.6%
5/9 • 1 year
|
100.0%
5/5 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
28.6%
2/7 • 1 year
|
33.3%
1/3 • 1 year
|
33.3%
1/3 • 1 year
|
11.1%
1/9 • 1 year
|
20.0%
1/5 • 1 year
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
1/7 • 1 year
|
33.3%
1/3 • 1 year
|
33.3%
1/3 • 1 year
|
11.1%
1/9 • 1 year
|
0.00%
0/5 • 1 year
|
|
Metabolism and nutrition disorders
Anorexia
|
28.6%
2/7 • 1 year
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • 1 year
|
22.2%
2/9 • 1 year
|
40.0%
2/5 • 1 year
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
14.3%
1/7 • 1 year
|
0.00%
0/3 • 1 year
|
66.7%
2/3 • 1 year
|
0.00%
0/9 • 1 year
|
60.0%
3/5 • 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
14.3%
1/7 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/9 • 1 year
|
0.00%
0/5 • 1 year
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/7 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
22.2%
2/9 • 1 year
|
0.00%
0/5 • 1 year
|
|
Nervous system disorders
Headache
|
0.00%
0/7 • 1 year
|
66.7%
2/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/9 • 1 year
|
0.00%
0/5 • 1 year
|
|
Investigations
Alanine aminotransferase increased
|
28.6%
2/7 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
22.2%
2/9 • 1 year
|
0.00%
0/5 • 1 year
|
|
General disorders
Fever
|
14.3%
1/7 • 1 year
|
33.3%
1/3 • 1 year
|
33.3%
1/3 • 1 year
|
11.1%
1/9 • 1 year
|
0.00%
0/5 • 1 year
|
|
Gastrointestinal disorders
Constipation
|
14.3%
1/7 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/9 • 1 year
|
20.0%
1/5 • 1 year
|
|
Metabolism and nutrition disorders
Hypernatremia
|
14.3%
1/7 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/9 • 1 year
|
0.00%
0/5 • 1 year
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
28.6%
2/7 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/9 • 1 year
|
40.0%
2/5 • 1 year
|
|
Metabolism and nutrition disorders
Hypokalemia
|
28.6%
2/7 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/9 • 1 year
|
0.00%
0/5 • 1 year
|
|
Metabolism and nutrition disorders
Hyponatremia
|
28.6%
2/7 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/9 • 1 year
|
0.00%
0/5 • 1 year
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
14.3%
1/7 • 1 year
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/9 • 1 year
|
20.0%
1/5 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/7 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/9 • 1 year
|
20.0%
1/5 • 1 year
|
|
Nervous system disorders
Abducens nerve disorder
|
0.00%
0/7 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
22.2%
2/9 • 1 year
|
0.00%
0/5 • 1 year
|
|
Investigations
Activated partial thromboplastin time prolonged
|
28.6%
2/7 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
11.1%
1/9 • 1 year
|
20.0%
1/5 • 1 year
|
|
Infections and infestations
Anorectal infection
|
0.00%
0/7 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
11.1%
1/9 • 1 year
|
0.00%
0/5 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
14.3%
1/7 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/9 • 1 year
|
0.00%
0/5 • 1 year
|
|
Nervous system disorders
Ataxia
|
14.3%
1/7 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/3 • 1 year
|
22.2%
2/9 • 1 year
|
0.00%
0/5 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/7 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/9 • 1 year
|
20.0%
1/5 • 1 year
|
|
Investigations
Blood bilirubin increased
|
14.3%
1/7 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
11.1%
1/9 • 1 year
|
0.00%
0/5 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/7 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
11.1%
1/9 • 1 year
|
20.0%
1/5 • 1 year
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/7 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/9 • 1 year
|
0.00%
0/5 • 1 year
|
|
General disorders
Chills
|
0.00%
0/7 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/9 • 1 year
|
20.0%
1/5 • 1 year
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/7 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/9 • 1 year
|
20.0%
1/5 • 1 year
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/7 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
11.1%
1/9 • 1 year
|
0.00%
0/5 • 1 year
|
|
Investigations
Creatinine increased
|
0.00%
0/7 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/9 • 1 year
|
20.0%
1/5 • 1 year
|
|
General disorders
Death NOS
|
14.3%
1/7 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/9 • 1 year
|
20.0%
1/5 • 1 year
|
|
Metabolism and nutrition disorders
Dehydration
|
14.3%
1/7 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/9 • 1 year
|
20.0%
1/5 • 1 year
|
|
Psychiatric disorders
Depression
|
0.00%
0/7 • 1 year
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/9 • 1 year
|
20.0%
1/5 • 1 year
|
|
Nervous system disorders
Dizziness
|
0.00%
0/7 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
11.1%
1/9 • 1 year
|
0.00%
0/5 • 1 year
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/7 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
11.1%
1/9 • 1 year
|
0.00%
0/5 • 1 year
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/7 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/3 • 1 year
|
11.1%
1/9 • 1 year
|
0.00%
0/5 • 1 year
|
|
Nervous system disorders
Dysgeusia
|
14.3%
1/7 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/9 • 1 year
|
0.00%
0/5 • 1 year
|
|
Nervous system disorders
Facial nerve disorder
|
0.00%
0/7 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
11.1%
1/9 • 1 year
|
0.00%
0/5 • 1 year
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/7 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
11.1%
1/9 • 1 year
|
0.00%
0/5 • 1 year
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
14.3%
1/7 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/9 • 1 year
|
0.00%
0/5 • 1 year
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/7 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
11.1%
1/9 • 1 year
|
0.00%
0/5 • 1 year
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
28.6%
2/7 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/9 • 1 year
|
20.0%
1/5 • 1 year
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
14.3%
1/7 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/9 • 1 year
|
0.00%
0/5 • 1 year
|
|
Vascular disorders
Hypertension
|
0.00%
0/7 • 1 year
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/9 • 1 year
|
0.00%
0/5 • 1 year
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
14.3%
1/7 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/9 • 1 year
|
40.0%
2/5 • 1 year
|
|
Vascular disorders
Hypotension
|
0.00%
0/7 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/9 • 1 year
|
20.0%
1/5 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/7 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
11.1%
1/9 • 1 year
|
0.00%
0/5 • 1 year
|
|
Infections and infestations
Infections and infestations - Other, specify
|
0.00%
0/7 • 1 year
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/9 • 1 year
|
0.00%
0/5 • 1 year
|
|
Investigations
INR increased
|
14.3%
1/7 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/9 • 1 year
|
20.0%
1/5 • 1 year
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/7 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/9 • 1 year
|
20.0%
1/5 • 1 year
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/7 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/9 • 1 year
|
20.0%
1/5 • 1 year
|
|
Gastrointestinal disorders
Mucositis oral
|
14.3%
1/7 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/9 • 1 year
|
0.00%
0/5 • 1 year
|
|
Nervous system disorders
Muscle weakness left-sided
|
14.3%
1/7 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/9 • 1 year
|
0.00%
0/5 • 1 year
|
|
Nervous system disorders
Muscle weakness right-sided
|
14.3%
1/7 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/9 • 1 year
|
0.00%
0/5 • 1 year
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
14.3%
1/7 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
11.1%
1/9 • 1 year
|
0.00%
0/5 • 1 year
|
|
Nervous system disorders
Nystagmus
|
14.3%
1/7 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/9 • 1 year
|
0.00%
0/5 • 1 year
|
|
Nervous system disorders
Oculomotor nerve disorder
|
0.00%
0/7 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
11.1%
1/9 • 1 year
|
0.00%
0/5 • 1 year
|
|
Eye disorders
Optic nerve disorder
|
0.00%
0/7 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/9 • 1 year
|
0.00%
0/5 • 1 year
|
|
General disorders
Pain
|
0.00%
0/7 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
11.1%
1/9 • 1 year
|
20.0%
1/5 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
14.3%
1/7 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/9 • 1 year
|
20.0%
1/5 • 1 year
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/7 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
11.1%
1/9 • 1 year
|
0.00%
0/5 • 1 year
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/7 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/9 • 1 year
|
20.0%
1/5 • 1 year
|
|
Nervous system disorders
Pyramidal tract syndrome
|
0.00%
0/7 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
11.1%
1/9 • 1 year
|
0.00%
0/5 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/7 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
11.1%
1/9 • 1 year
|
0.00%
0/5 • 1 year
|
|
Nervous system disorders
Seizure
|
0.00%
0/7 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/9 • 1 year
|
0.00%
0/5 • 1 year
|
|
Infections and infestations
Sepsis
|
14.3%
1/7 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/9 • 1 year
|
20.0%
1/5 • 1 year
|
|
Cardiac disorders
Sinus tachycardia
|
14.3%
1/7 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/9 • 1 year
|
20.0%
1/5 • 1 year
|
|
Skin and subcutaneous tissue disorders
Skin & subcutaneous tissue disorders Other, spec
|
0.00%
0/7 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
11.1%
1/9 • 1 year
|
0.00%
0/5 • 1 year
|
|
Infections and infestations
Skin infection
|
0.00%
0/7 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
11.1%
1/9 • 1 year
|
0.00%
0/5 • 1 year
|
|
Nervous system disorders
Somnolence
|
14.3%
1/7 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/9 • 1 year
|
0.00%
0/5 • 1 year
|
|
Infections and infestations
Upper respiratory infection
|
14.3%
1/7 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/9 • 1 year
|
0.00%
0/5 • 1 year
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/7 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/9 • 1 year
|
20.0%
1/5 • 1 year
|
|
Investigations
Urine output decreased
|
0.00%
0/7 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/9 • 1 year
|
20.0%
1/5 • 1 year
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/7 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/9 • 1 year
|
20.0%
1/5 • 1 year
|
|
Investigations
Weight loss
|
0.00%
0/7 • 1 year
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/9 • 1 year
|
0.00%
0/5 • 1 year
|
Additional Information
Tanya Trippett, MD
Memorial Sloan Kettering Cancer Center
Phone: 1-833-MSK-KIDS
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place