Trial Outcomes & Findings for Vinorelbine Tartrate and Cyclophosphamide in Combination With Bevacizumab or Temsirolimus in Treating Patients With Recurrent or Refractory Rhabdomyosarcoma (NCT NCT01222715)
NCT ID: NCT01222715
Last Updated: 2017-05-05
Results Overview
Probability of no relapse, secondary malignancy, or death after 1 year in the study.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
87 participants
Primary outcome timeframe
1 year
Results posted on
2017-05-05
Participant Flow
Participant milestones
| Measure |
Regimen A
The cyclophosphamide plus vinorelbine combination was administered at 1.2 g/m2 every 3 weeks and 25 mg/m2/dose (administered weekly on the first 2 out of every 3 weeks), respectively. Bevacizumab was administered at 15 mg/kg every 3 weeks.
|
Regimen B
The cyclophosphamide plus vinorelbine combination was administered at 1.2 g/m2 every 3 weeks and 25 mg/m2/dose (administered weekly on the first 2 out of every 3 weeks), respectively. Temsirolimus was administered at 15 mg/m2/week intravenously.
|
|---|---|---|
|
Overall Study
STARTED
|
44
|
43
|
|
Overall Study
COMPLETED
|
8
|
16
|
|
Overall Study
NOT COMPLETED
|
36
|
27
|
Reasons for withdrawal
| Measure |
Regimen A
The cyclophosphamide plus vinorelbine combination was administered at 1.2 g/m2 every 3 weeks and 25 mg/m2/dose (administered weekly on the first 2 out of every 3 weeks), respectively. Bevacizumab was administered at 15 mg/kg every 3 weeks.
|
Regimen B
The cyclophosphamide plus vinorelbine combination was administered at 1.2 g/m2 every 3 weeks and 25 mg/m2/dose (administered weekly on the first 2 out of every 3 weeks), respectively. Temsirolimus was administered at 15 mg/m2/week intravenously.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
4
|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Lack of Efficacy
|
22
|
14
|
|
Overall Study
Physician Decision
|
12
|
2
|
|
Overall Study
Refusal of further protocol therapy
|
0
|
4
|
|
Overall Study
Pt cannot receive treatment for >9 wks
|
1
|
1
|
|
Overall Study
Ineligible
|
0
|
1
|
|
Overall Study
Surgery or radiation therapy in 1st 6 wk
|
1
|
0
|
Baseline Characteristics
Vinorelbine Tartrate and Cyclophosphamide in Combination With Bevacizumab or Temsirolimus in Treating Patients With Recurrent or Refractory Rhabdomyosarcoma
Baseline characteristics by cohort
| Measure |
Regimen A
n=44 Participants
The cyclophosphamide plus vinorelbine combination was administered at 1.2 g/m2 every 3 weeks and 25 mg/m2/dose (administered weekly on the first 2 out of every 3 weeks), respectively. Bevacizumab was administered at 15 mg/kg every 3 weeks.
|
Regimen B
n=43 Participants
The cyclophosphamide plus vinorelbine combination was administered at 1.2 g/m2 every 3 weeks and 25 mg/m2/dose (administered weekly on the first 2 out of every 3 weeks), respectively. Temsirolimus was administered at 15 mg/m2/week intravenously.
|
Total
n=87 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
116.35 Months
STANDARD_DEVIATION 72.82 • n=5 Participants
|
140.65 Months
STANDARD_DEVIATION 75.93 • n=7 Participants
|
128.36 Months
STANDARD_DEVIATION 74.94 • n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
35 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: Only eligible participants were analyzed.
Probability of no relapse, secondary malignancy, or death after 1 year in the study.
Outcome measures
| Measure |
Regimen A
n=44 Participants
The cyclophosphamide plus vinorelbine combination was administered at 1.2 g/m2 every 3 weeks and 25 mg/m2/dose (administered weekly on the first 2 out of every 3 weeks), respectively. Bevacizumab was administered at 15 mg/kg every 3 weeks.
|
Regimen B
n=42 Participants
The cyclophosphamide plus vinorelbine combination was administered at 1.2 g/m2 every 3 weeks and 25 mg/m2/dose (administered weekly on the first 2 out of every 3 weeks), respectively. Temsirolimus was administered at 15 mg/m2/week intravenously.
|
|---|---|---|
|
Event Free Survival Probability
|
0.23 Probability
Interval 0.1 to 0.35
|
0.43 Probability
Interval 0.28 to 0.58
|
PRIMARY outcome
Timeframe: From the date of randomization until a maximum of 12 cycles (21 days per cycle) of treatment in the absence of disease progression or unacceptable toxicities.Population: Only eligible participants were analyzed.
The following events will be considered dose-limiting toxicities (DLTs): Toxicity causing delays \> 14 days in delivery of a 21-day cycle of therapy; Grade ≥ 3 mucositis \> 3 days duration; Grade ≥ 3 thromboembolic events; Grade ≥ 3 bleeding events; Grade ≥ 3 pulmonary events; Grade ≥ 3 hypertension; Grade 3 hyperglycemia (uncontrolled); Grade ≥ 4 hyperglycemia; Grade ≥ 4 hyperlipidemia (including cholesterol and triglycerides) that does not return to ≤ Grade 2 levels with appropriate medical management within 35 days; Grade ≥ 2 perforation including fistula or leak (gastrointestinal or any other organ); Grade ≥ 3 proteinuria; Grade ≥ 3 cardiac toxicity; Grade ≥ 3 intra-abdominal abscess/infection; Grade ≥ 3 wound complication (wound infection or dehiscence); Grade ≥ 1 Reversible Posterior Leukoencephalopathy Syndrome (RPLS); Grade ≥ 1 Microangiopathy, or Hemolytic-uremic syndrome (HUS) or Thrombotic thrombocytopenic Purpura (TTP).
Outcome measures
| Measure |
Regimen A
n=44 Participants
The cyclophosphamide plus vinorelbine combination was administered at 1.2 g/m2 every 3 weeks and 25 mg/m2/dose (administered weekly on the first 2 out of every 3 weeks), respectively. Bevacizumab was administered at 15 mg/kg every 3 weeks.
|
Regimen B
n=42 Participants
The cyclophosphamide plus vinorelbine combination was administered at 1.2 g/m2 every 3 weeks and 25 mg/m2/dose (administered weekly on the first 2 out of every 3 weeks), respectively. Temsirolimus was administered at 15 mg/m2/week intravenously.
|
|---|---|---|
|
Rate of Dose-Limiting Toxicities
|
2 Percentage of participants
Interval 0.0 to 7.0
|
21 Percentage of participants
Interval 9.0 to 34.0
|
SECONDARY outcome
Timeframe: From the date of randomization until a maximum of 2 cycles (21 days per cycle) of treatment in the absence of disease progression or unacceptable toxicities.Population: Only eligible participants with overall response evaluated were analyzed.
Complete or partial anatomical response rate. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Regimen A
n=40 Participants
The cyclophosphamide plus vinorelbine combination was administered at 1.2 g/m2 every 3 weeks and 25 mg/m2/dose (administered weekly on the first 2 out of every 3 weeks), respectively. Bevacizumab was administered at 15 mg/kg every 3 weeks.
|
Regimen B
n=38 Participants
The cyclophosphamide plus vinorelbine combination was administered at 1.2 g/m2 every 3 weeks and 25 mg/m2/dose (administered weekly on the first 2 out of every 3 weeks), respectively. Temsirolimus was administered at 15 mg/m2/week intravenously.
|
|---|---|---|
|
Response Rate (CR + PR)
|
0.3250 Proportion of participants
Interval 0.1799 to 0.4701
|
0.4737 Proportion of participants
Interval 0.3149 to 0.6324
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 36 weeksBiomarker data will be summarized for each response category, at each time point using either means and standard deviations or medians and ranges.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to day 42First, the distributions of these markers will be compared at 'end of 2 cycles' between treatments using a 2-independent sample non-parametric test. The mean will also be modeled for each of these markers (or a transformation of the marker to near normality) as a function of time and treatment using GEEs which are designed to take into account the internal correlation of repeated measurements taken on the same subject. Associations between progression-free survival and changes in each of the biomarkers will be investigated using univariate Cox proportional hazards regression analysis.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 5 yearsThese known risk factors will be compared to genomic features like gene and ribonucleic acid (RNA) expression values, as well as combinations of the two and splice variants of known genes, in order to identify those features most related to treatment resistance and poor outcome (overall survival and failure-free survival) using a Cox proportional hazards model of gene expression with cross validation.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 5 yearsThe data reported in 2 groups will be summarized using numbers and percentages of patients in each stratum and at each time point (baseline, after course 2, at the time of best response and end of therapy or progressive disease, whichever comes first). A binomial generalized estimating equation (GEE) model will be fitted to the data. The variables in the model will be time, treatment group and a biomarker. The beta coefficient of the biomarker will quantify the strength of the association between clinical response and the biomarker, beyond the association of the outcome to the other variables.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 36 weeksOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 5 yearsProgression-free survival data will be explored using Kaplan Meier analysis. Associations between this outcome and each of the biomarkers will be investigated using univariate Cox proportional hazards regression analysis.
Outcome measures
Outcome data not reported
Adverse Events
Regimen A
Serious events: 35 serious events
Other events: 28 other events
Deaths: 0 deaths
Regimen B
Serious events: 32 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Regimen A
n=44 participants at risk
Vinorelbine/cyclophosphamide (VC) + bevacizumab
|
Regimen B
n=42 participants at risk
Vinorelbine/cyclophosphamide (VC) + temsirolimus
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
2.3%
1/44 • Number of events 1
|
0.00%
0/42
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/44
|
2.4%
1/42 • Number of events 1
|
|
Blood and lymphatic system disorders
Anemia
|
2.3%
1/44 • Number of events 1
|
2.4%
1/42 • Number of events 1
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/44
|
2.4%
1/42 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/44
|
2.4%
1/42 • Number of events 1
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/44
|
2.4%
1/42 • Number of events 1
|
|
Investigations
CPK increased
|
0.00%
0/44
|
2.4%
1/42 • Number of events 1
|
|
General disorders
Death NOS
|
61.4%
27/44 • Number of events 27
|
35.7%
15/42 • Number of events 15
|
|
Metabolism and nutrition disorders
Dehydration
|
2.3%
1/44 • Number of events 1
|
7.1%
3/42 • Number of events 4
|
|
Gastrointestinal disorders
Dental caries
|
2.3%
1/44 • Number of events 1
|
0.00%
0/42
|
|
Gastrointestinal disorders
Diarrhea
|
2.3%
1/44 • Number of events 1
|
2.4%
1/42 • Number of events 2
|
|
Investigations
Ejection fraction decreased
|
2.3%
1/44 • Number of events 1
|
0.00%
0/42
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.5%
2/44 • Number of events 2
|
0.00%
0/42
|
|
Infections and infestations
Esophageal infection
|
0.00%
0/44
|
2.4%
1/42 • Number of events 1
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/44
|
2.4%
1/42 • Number of events 2
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
9.1%
4/44 • Number of events 7
|
21.4%
9/42 • Number of events 15
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
2.3%
1/44 • Number of events 1
|
0.00%
0/42
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
0.00%
0/44
|
9.5%
4/42 • Number of events 6
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/44
|
4.8%
2/42 • Number of events 2
|
|
Vascular disorders
Hypotension
|
0.00%
0/44
|
4.8%
2/42 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/44
|
2.4%
1/42 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukemia secondary to oncology chemotherapy
|
0.00%
0/44
|
2.4%
1/42 • Number of events 1
|
|
Investigations
Lymphocyte count decreased
|
2.3%
1/44 • Number of events 1
|
0.00%
0/42
|
|
Gastrointestinal disorders
Mucositis oral
|
2.3%
1/44 • Number of events 1
|
14.3%
6/42 • Number of events 6
|
|
Gastrointestinal disorders
Nausea
|
2.3%
1/44 • Number of events 1
|
2.4%
1/42 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
6.8%
3/44 • Number of events 3
|
16.7%
7/42 • Number of events 7
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/44
|
4.8%
2/42 • Number of events 2
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/44
|
2.4%
1/42 • Number of events 1
|
|
General disorders
Pain
|
2.3%
1/44 • Number of events 1
|
0.00%
0/42
|
|
Investigations
Platelet count decreased
|
0.00%
0/44
|
2.4%
1/42 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/44
|
4.8%
2/42 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/44
|
2.4%
1/42 • Number of events 1
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other, specify
|
2.3%
1/44 • Number of events 2
|
0.00%
0/42
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.3%
1/44 • Number of events 1
|
2.4%
1/42 • Number of events 1
|
|
Infections and infestations
Sepsis
|
6.8%
3/44 • Number of events 3
|
0.00%
0/42
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
2.3%
1/44 • Number of events 4
|
0.00%
0/42
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/44
|
2.4%
1/42 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
2.3%
1/44 • Number of events 1
|
0.00%
0/42
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Treatment related secondary malignancy
|
2.3%
1/44 • Number of events 2
|
2.4%
1/42 • Number of events 1
|
|
Gastrointestinal disorders
Typhlitis
|
0.00%
0/44
|
2.4%
1/42 • Number of events 1
|
|
Renal and urinary disorders
Urinary tract obstruction
|
2.3%
1/44 • Number of events 1
|
0.00%
0/42
|
|
Gastrointestinal disorders
Vomiting
|
2.3%
1/44 • Number of events 1
|
2.4%
1/42 • Number of events 1
|
|
Investigations
Weight loss
|
0.00%
0/44
|
2.4%
1/42 • Number of events 1
|
|
Infections and infestations
Wound infection
|
0.00%
0/44
|
2.4%
1/42 • Number of events 1
|
Other adverse events
| Measure |
Regimen A
n=44 participants at risk
Vinorelbine/cyclophosphamide (VC) + bevacizumab
|
Regimen B
n=42 participants at risk
Vinorelbine/cyclophosphamide (VC) + temsirolimus
|
|---|---|---|
|
Investigations
Creatinine increased
|
0.00%
0/44
|
2.4%
1/42 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/44
|
9.5%
4/42 • Number of events 4
|
|
Investigations
Activated partial thromboplastin time prolonged
|
4.5%
2/44 • Number of events 2
|
0.00%
0/42
|
|
Endocrine disorders
Adrenal insufficiency
|
2.3%
1/44 • Number of events 1
|
0.00%
0/42
|
|
Investigations
Alanine aminotransferase increased
|
2.3%
1/44 • Number of events 1
|
11.9%
5/42 • Number of events 8
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/44
|
2.4%
1/42 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/44
|
2.4%
1/42 • Number of events 1
|
|
Blood and lymphatic system disorders
Anemia
|
15.9%
7/44 • Number of events 8
|
19.0%
8/42 • Number of events 8
|
|
Metabolism and nutrition disorders
Anorexia
|
4.5%
2/44 • Number of events 3
|
4.8%
2/42 • Number of events 2
|
|
Psychiatric disorders
Anxiety
|
4.5%
2/44 • Number of events 2
|
7.1%
3/42 • Number of events 3
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/44
|
2.4%
1/42 • Number of events 1
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/44
|
7.1%
3/42 • Number of events 4
|
|
Nervous system disorders
Ataxia
|
0.00%
0/44
|
2.4%
1/42 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.4%
5/44 • Number of events 5
|
7.1%
3/42 • Number of events 3
|
|
Investigations
Blood bilirubin increased
|
2.3%
1/44 • Number of events 1
|
0.00%
0/42
|
|
Investigations
Cholesterol high
|
2.3%
1/44 • Number of events 1
|
2.4%
1/42 • Number of events 1
|
|
Eye disorders
Conjunctivitis
|
4.5%
2/44 • Number of events 2
|
0.00%
0/42
|
|
Gastrointestinal disorders
Constipation
|
2.3%
1/44 • Number of events 1
|
2.4%
1/42 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.3%
1/44 • Number of events 1
|
0.00%
0/42
|
|
Gastrointestinal disorders
Dental caries
|
2.3%
1/44 • Number of events 1
|
0.00%
0/42
|
|
Psychiatric disorders
Depression
|
4.5%
2/44 • Number of events 2
|
4.8%
2/42 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhea
|
2.3%
1/44 • Number of events 1
|
2.4%
1/42 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/44
|
4.8%
2/42 • Number of events 2
|
|
General disorders
Edema face
|
0.00%
0/44
|
2.4%
1/42 • Number of events 1
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/44
|
2.4%
1/42 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.3%
1/44 • Number of events 2
|
0.00%
0/42
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/44
|
2.4%
1/42 • Number of events 1
|
|
Eye disorders
Eye disorders - Other, specify
|
2.3%
1/44 • Number of events 1
|
0.00%
0/42
|
|
Eye disorders
Eye pain
|
2.3%
1/44 • Number of events 1
|
0.00%
0/42
|
|
Eye disorders
Eyelid function disorder
|
0.00%
0/44
|
2.4%
1/42 • Number of events 1
|
|
Nervous system disorders
Facial muscle weakness
|
2.3%
1/44 • Number of events 1
|
0.00%
0/42
|
|
Nervous system disorders
Facial nerve disorder
|
2.3%
1/44 • Number of events 1
|
0.00%
0/42
|
|
General disorders
Facial pain
|
2.3%
1/44 • Number of events 1
|
0.00%
0/42
|
|
General disorders
Fatigue
|
2.3%
1/44 • Number of events 1
|
2.4%
1/42 • Number of events 1
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
15.9%
7/44 • Number of events 12
|
16.7%
7/42 • Number of events 20
|
|
General disorders
Fever
|
0.00%
0/44
|
2.4%
1/42 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
2.3%
1/44 • Number of events 1
|
0.00%
0/42
|
|
Nervous system disorders
Headache
|
2.3%
1/44 • Number of events 1
|
0.00%
0/42
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/44
|
2.4%
1/42 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
11.4%
5/44 • Number of events 5
|
9.5%
4/42 • Number of events 6
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
2.3%
1/44 • Number of events 1
|
0.00%
0/42
|
|
Vascular disorders
Hypertension
|
2.3%
1/44 • Number of events 1
|
2.4%
1/42 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
2.3%
1/44 • Number of events 1
|
11.9%
5/42 • Number of events 5
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
15.9%
7/44 • Number of events 7
|
2.4%
1/42 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
2.3%
1/44 • Number of events 1
|
2.4%
1/42 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypokalemia
|
2.3%
1/44 • Number of events 2
|
11.9%
5/42 • Number of events 10
|
|
Metabolism and nutrition disorders
Hyponatremia
|
6.8%
3/44 • Number of events 3
|
2.4%
1/42 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
2.3%
1/44 • Number of events 1
|
4.8%
2/42 • Number of events 2
|
|
Vascular disorders
Hypotension
|
0.00%
0/44
|
2.4%
1/42 • Number of events 1
|
|
Endocrine disorders
Hypothyroidism
|
2.3%
1/44 • Number of events 1
|
0.00%
0/42
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/44
|
4.8%
2/42 • Number of events 2
|
|
Gastrointestinal disorders
Ileus
|
2.3%
1/44 • Number of events 1
|
2.4%
1/42 • Number of events 2
|
|
Infections and infestations
Infections and infestations - Other, specify
|
2.3%
1/44 • Number of events 2
|
0.00%
0/42
|
|
Investigations
INR increased
|
2.3%
1/44 • Number of events 1
|
0.00%
0/42
|
|
Investigations
Investigations - Other, specify
|
2.3%
1/44 • Number of events 1
|
0.00%
0/42
|
|
Eye disorders
Keratitis
|
2.3%
1/44 • Number of events 1
|
0.00%
0/42
|
|
Vascular disorders
Lymphedema
|
0.00%
0/44
|
2.4%
1/42 • Number of events 1
|
|
Investigations
Lymphocyte count decreased
|
13.6%
6/44 • Number of events 11
|
14.3%
6/42 • Number of events 9
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/44
|
2.4%
1/42 • Number of events 1
|
|
Gastrointestinal disorders
Mucositis oral
|
2.3%
1/44 • Number of events 1
|
4.8%
2/42 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/44
|
2.4%
1/42 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
0.00%
0/44
|
2.4%
1/42 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.3%
1/44 • Number of events 1
|
0.00%
0/42
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/44
|
2.4%
1/42 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
2.3%
1/44 • Number of events 1
|
0.00%
0/42
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/44
|
2.4%
1/42 • Number of events 1
|
|
Investigations
Neutrophil count decreased
|
6.8%
3/44 • Number of events 12
|
9.5%
4/42 • Number of events 6
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/44
|
2.4%
1/42 • Number of events 1
|
|
Nervous system disorders
Oculomotor nerve disorder
|
0.00%
0/44
|
2.4%
1/42 • Number of events 1
|
|
Gastrointestinal disorders
Oral pain
|
2.3%
1/44 • Number of events 1
|
0.00%
0/42
|
|
General disorders
Pain
|
13.6%
6/44 • Number of events 6
|
4.8%
2/42 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/44
|
2.4%
1/42 • Number of events 1
|
|
Infections and infestations
Pelvic infection
|
0.00%
0/44
|
2.4%
1/42 • Number of events 1
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/44
|
2.4%
1/42 • Number of events 1
|
|
Nervous system disorders
Peripheral motor neuropathy
|
2.3%
1/44 • Number of events 1
|
4.8%
2/42 • Number of events 2
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/44
|
7.1%
3/42 • Number of events 3
|
|
Eye disorders
Photophobia
|
2.3%
1/44 • Number of events 1
|
0.00%
0/42
|
|
Investigations
Platelet count decreased
|
13.6%
6/44 • Number of events 9
|
9.5%
4/42 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/44
|
7.1%
3/42 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/44
|
2.4%
1/42 • Number of events 1
|
|
Renal and urinary disorders
Proteinuria
|
2.3%
1/44 • Number of events 1
|
0.00%
0/42
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
2.3%
1/44 • Number of events 1
|
0.00%
0/42
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
2.3%
1/44 • Number of events 1
|
0.00%
0/42
|
|
Renal and urinary disorders
Renal calculi
|
0.00%
0/44
|
2.4%
1/42 • Number of events 1
|
|
Infections and infestations
Skin infection
|
0.00%
0/44
|
2.4%
1/42 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
2.3%
1/44 • Number of events 1
|
0.00%
0/42
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
0.00%
0/44
|
2.4%
1/42 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
2.3%
1/44 • Number of events 1
|
7.1%
3/42 • Number of events 3
|
|
Infections and infestations
Upper respiratory infection
|
2.3%
1/44 • Number of events 1
|
0.00%
0/42
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/44
|
2.4%
1/42 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/44
|
2.4%
1/42 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
2.3%
1/44 • Number of events 1
|
0.00%
0/42
|
|
Investigations
White blood cell decreased
|
11.4%
5/44 • Number of events 10
|
11.9%
5/42 • Number of events 6
|
|
Infections and infestations
Wound infection
|
2.3%
1/44 • Number of events 1
|
0.00%
0/42
|
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
Restriction type: LTE60