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Trial Outcomes & Findings for Combination Chemotherapy, Radiation Therapy, and/or Surgery in Treating Patients With High-Risk Kidney Tumors (NCT NCT00335556)

NCT ID: NCT00335556

Last Updated: 2017-07-21

Results Overview

Compare the outcome of patients treated with alternating CyCE/VDCy chemotherapy (with or without vincristine/irinotecan cycles) to a fixed outcome based on that seen for similar patients treated with NWTS-5 (NCT00002610).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

291 participants

Primary outcome timeframe

4 years

Results posted on

2017-07-21

Participant Flow

Participant milestones

Participant milestones
Measure
Surgery
Surgery Only
UH-1
Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT.
Window/UH-1
Window therapy of vincristine/irinotecan;Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT.
UH-2
Window therapy of vincristine/irinotecan;Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 36 weeks; XRT.
Regimen I
Vincristine/doxorubicin/cyclophosphamide; cyclophosphamide/etoposide x25 weeks; XRT.
Regimen DD-4A
Vincristine/dactinomycin/doxorubicin x25 weeks; XRT.
Overall Study
STARTED
68
98
7
10
78
30
Overall Study
COMPLETED
66
64
2
5
77
29
Overall Study
NOT COMPLETED
2
34
5
5
1
1

Reasons for withdrawal

Reasons for withdrawal
Measure
Surgery
Surgery Only
UH-1
Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT.
Window/UH-1
Window therapy of vincristine/irinotecan;Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT.
UH-2
Window therapy of vincristine/irinotecan;Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 36 weeks; XRT.
Regimen I
Vincristine/doxorubicin/cyclophosphamide; cyclophosphamide/etoposide x25 weeks; XRT.
Regimen DD-4A
Vincristine/dactinomycin/doxorubicin x25 weeks; XRT.
Overall Study
Death
0
5
0
0
1
0
Overall Study
Lack of Efficacy
0
19
3
3
0
1
Overall Study
Physician Decision
0
6
2
1
0
0
Overall Study
Ineligible
2
0
0
0
0
0
Overall Study
Refusal of further protocol therapy
0
4
0
1
0
0

Baseline Characteristics

Combination Chemotherapy, Radiation Therapy, and/or Surgery in Treating Patients With High-Risk Kidney Tumors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Surgery
n=68 Participants
Surgery Only
UH-1
n=98 Participants
Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT.
Window/UH-1
n=7 Participants
Window therapy of vincristine/irinotecan;Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT.
UH-2
n=10 Participants
Window therapy of vincristine/irinotecan;Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 36 weeks; XRT.
Regimen I
n=78 Participants
Vincristine/doxorubicin/cyclophosphamide; cyclophosphamide/etoposide x25 weeks; XRT.
Regimen DD-4A
n=30 Participants
Vincristine/dactinomycin/doxorubicin x25 weeks; XRT.
Total
n=291 Participants
Total of all reporting groups
Age, Continuous
148.53 Months
STANDARD_DEVIATION 51.74 • n=5 Participants
52.39 Months
STANDARD_DEVIATION 40.09 • n=7 Participants
68.95 Months
STANDARD_DEVIATION 97.64 • n=5 Participants
54.04 Months
STANDARD_DEVIATION 19.71 • n=4 Participants
34.10 Months
STANDARD_DEVIATION 31.10 • n=21 Participants
54.29 Months
STANDARD_DEVIATION 32.72 • n=8 Participants
70.60 Months
STANDARD_DEVIATION 60.50 • n=8 Participants
Sex: Female, Male
Female
28 Participants
n=5 Participants
55 Participants
n=7 Participants
5 Participants
n=5 Participants
7 Participants
n=4 Participants
31 Participants
n=21 Participants
11 Participants
n=8 Participants
137 Participants
n=8 Participants
Sex: Female, Male
Male
40 Participants
n=5 Participants
43 Participants
n=7 Participants
2 Participants
n=5 Participants
3 Participants
n=4 Participants
47 Participants
n=21 Participants
19 Participants
n=8 Participants
154 Participants
n=8 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
5 Participants
n=5 Participants
8 Participants
n=7 Participants
0 Participants
n=5 Participants
2 Participants
n=4 Participants
15 Participants
n=21 Participants
4 Participants
n=8 Participants
34 Participants
n=8 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
63 Participants
n=5 Participants
88 Participants
n=7 Participants
6 Participants
n=5 Participants
8 Participants
n=4 Participants
63 Participants
n=21 Participants
25 Participants
n=8 Participants
253 Participants
n=8 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
2 Participants
n=7 Participants
1 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
1 Participants
n=8 Participants
4 Participants
n=8 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
0 Participants
n=8 Participants
Race (NIH/OMB)
Asian
1 Participants
n=5 Participants
1 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
3 Participants
n=21 Participants
0 Participants
n=8 Participants
5 Participants
n=8 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
1 Participants
n=8 Participants
Race (NIH/OMB)
Black or African American
22 Participants
n=5 Participants
17 Participants
n=7 Participants
1 Participants
n=5 Participants
2 Participants
n=4 Participants
13 Participants
n=21 Participants
5 Participants
n=8 Participants
60 Participants
n=8 Participants
Race (NIH/OMB)
White
40 Participants
n=5 Participants
72 Participants
n=7 Participants
5 Participants
n=5 Participants
8 Participants
n=4 Participants
55 Participants
n=21 Participants
22 Participants
n=8 Participants
202 Participants
n=8 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
0 Participants
n=8 Participants
Race (NIH/OMB)
Unknown or Not Reported
4 Participants
n=5 Participants
8 Participants
n=7 Participants
1 Participants
n=5 Participants
0 Participants
n=4 Participants
7 Participants
n=21 Participants
3 Participants
n=8 Participants
23 Participants
n=8 Participants

PRIMARY outcome

Timeframe: 4 years

Population: Eligible patients with Stage II-IV DAWT.

Compare the outcome of patients treated with alternating CyCE/VDCy chemotherapy (with or without vincristine/irinotecan cycles) to a fixed outcome based on that seen for similar patients treated with NWTS-5 (NCT00002610).

Outcome measures

Outcome measures
Measure
UH-1
n=52 Participants
Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT.
Window/UH-1
n=4 Participants
Window therapy of vincristine/irinotecan;Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT.
UH-2
n=10 Participants
Window therapy of vincristine/irinotecan;Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 36 weeks; XRT.
Regimen DD-4A
Vincristine/dactinomycin/doxorubicin x25 weeks; XRT
Event-Free Survival of Patients With Diffuse Anaplastic Wilms' Tumor (DAWT)
76.1 Percentage of 4-year OS
Interval 62.5 to 89.6
25.0 Percentage of 4-year OS
Interval 0.0 to 67.4
87.5 Percentage of 4-year OS
Interval 64.6 to 100.0
—

PRIMARY outcome

Timeframe: 4 years

Population: Eligible patients with Stage I-IV rhabdoid tumor.

The outcome of these patients will be compared with a fixed outcome based on that seen for similar patients treated with NWTS-5 regimen (NCT00002610).

Outcome measures

Outcome measures
Measure
UH-1
n=36 Participants
Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT.
Window/UH-1
Window therapy of vincristine/irinotecan;Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT.
UH-2
Window therapy of vincristine/irinotecan;Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 36 weeks; XRT.
Regimen DD-4A
Vincristine/dactinomycin/doxorubicin x25 weeks; XRT
Long-term Survival of Patients With Stage I-IV Malignant Rhabdoid Tumors
38.9 Percentage of 4-year OS
Interval 20.1 to 57.7
—
—
—

PRIMARY outcome

Timeframe: Up to 2 months

Criteria for response assessed by three-dimensional measurement: Complete Response (CR), Disappearance of all index lesions and non-index lesions. No new lesions; Partial Response (PR), At least a 65% decrease in the sum of the volumes of the index lesions. No new lesions; Response rate (RR) = CR+PR of patients who received window therapy.

Outcome measures

Outcome measures
Measure
UH-1
n=17 Participants
Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT.
Window/UH-1
Window therapy of vincristine/irinotecan;Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT.
UH-2
Window therapy of vincristine/irinotecan;Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 36 weeks; XRT.
Regimen DD-4A
Vincristine/dactinomycin/doxorubicin x25 weeks; XRT
Response Rate
71 Percentage of participants
Interval 49.0 to 92.0
—
—
—

PRIMARY outcome

Timeframe: 4 years

Population: Eligible patients with Stage I focal and diffuse anaplastic Wilms tumor.

Event-free survival will be informally compared to that seem for similar patients treated on NWTS-5 (NCT00002610).

Outcome measures

Outcome measures
Measure
UH-1
n=18 Participants
Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT.
Window/UH-1
Window therapy of vincristine/irinotecan;Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT.
UH-2
Window therapy of vincristine/irinotecan;Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 36 weeks; XRT.
Regimen DD-4A
Vincristine/dactinomycin/doxorubicin x25 weeks; XRT
Event Free Survival Probability
100.0 Percent Probability 4 Year EFS
Interval 100.0 to 100.0
—
—
—

PRIMARY outcome

Timeframe: Up to 4 years

Population: Eligible patients treated after Amendment 3A for arms UH-1, UH-2, and Window/UH-1.

Percentage of participants with Grade 4 cardiac toxicities, Grade 4 Sinusoidal Obstruction Syndrome (SOS), and treatment-related deaths determined using CTCAE v4.

Outcome measures

Outcome measures
Measure
UH-1
n=61 Participants
Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT.
Window/UH-1
Window therapy of vincristine/irinotecan;Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT.
UH-2
Window therapy of vincristine/irinotecan;Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 36 weeks; XRT.
Regimen DD-4A
Vincristine/dactinomycin/doxorubicin x25 weeks; XRT
Toxicity Rate
Cardiac toxicities
4.9 Percentage of patients
Interval 0.0 to 10.3
—
—
—
Toxicity Rate
Treatment-related deaths
4.9 Percentage of patients
Interval 0.0 to 10.3
—
—
—
Toxicity Rate
Sinusoidal Obstruction Syndrome
0 Percentage of patients
Interval 0.0 to 0.0
—
—
—

SECONDARY outcome

Timeframe: At baseline

Population: Eligible patients with reported INI1 mutation data.

Outcome measures

Outcome measures
Measure
UH-1
n=26 Participants
Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT.
Window/UH-1
n=1 Participants
Window therapy of vincristine/irinotecan;Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT.
UH-2
Window therapy of vincristine/irinotecan;Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 36 weeks; XRT.
Regimen DD-4A
Vincristine/dactinomycin/doxorubicin x25 weeks; XRT
Number of Patients With INI1 Mutations in Renal and Extrarenal Malignant Rhabdoid Tumor by Fluorescent in Situ Hybridization
23 Count participants
1 Count participants
—
—

SECONDARY outcome

Timeframe: At baseline

Population: The analysis was supplanted by an analysis done as part of the TARGET initiative on NWTS-5 sample as a result no TP53 data was collected on AREN0321.

Outcome measures

Outcome data not reported

Adverse Events

Surgery

Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths

UH-1

Serious events: 19 serious events
Other events: 81 other events
Deaths: 0 deaths

Window/UH-1

Serious events: 3 serious events
Other events: 5 other events
Deaths: 0 deaths

UH-2

Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths

Regimen I

Serious events: 3 serious events
Other events: 7 other events
Deaths: 0 deaths

Regimen DD-4A

Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Surgery
n=66 participants at risk
Surgery Only
UH-1
n=98 participants at risk
Cyclophosphamide/carboplatin/etoposide;vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT
Window/UH-1
n=7 participants at risk
Window therapy of vincristine/irinotecan; Cyclophosphamide/carboplatin/etoposide;vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT"
UH-2
n=10 participants at risk
Window therapy of vincristine/irinotecan;Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 36 weeks; XRT
Regimen I
n=78 participants at risk
Vincristine/doxorubicin/cyclophosphamide; cyclophosphamide/etoposide x25 weeks; XRT
Regimen DD-4A
n=30 participants at risk
Vincristine/dactinomycin/doxorubicin x25 weeks; XRT"
Gastrointestinal disorders
10300-Abdominal pain
0.00%
0/66
0.00%
0/98
14.3%
1/7 • Number of events 1
0.00%
0/10
0.00%
0/78
0.00%
0/30
Renal and urinary disorders
11100-Acute kidney injury
0.00%
0/66
1.0%
1/98 • Number of events 1
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
Respiratory, thoracic and mediastinal disorders
11300-Adult respiratory distress syndrome
0.00%
0/66
2.0%
2/98 • Number of events 2
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
Investigations
11600-Alanine aminotransferase increased
0.00%
0/66
1.0%
1/98 • Number of events 1
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
Gastrointestinal disorders
14900-Ascites
0.00%
0/66
2.0%
2/98 • Number of events 2
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
Investigations
15000-Aspartate aminotransferase increased
0.00%
0/66
1.0%
1/98 • Number of events 1
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
Investigations
17400-Blood bilirubin increased
0.00%
0/66
2.0%
2/98 • Number of events 2
14.3%
1/7 • Number of events 1
0.00%
0/10
0.00%
0/78
0.00%
0/30
Respiratory, thoracic and mediastinal disorders
19200-Bronchopulmonary hemorrhage
0.00%
0/66
1.0%
1/98 • Number of events 1
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
Cardiac disorders
20000-Cardiac arrest
0.00%
0/66
1.0%
1/98 • Number of events 1
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
Cardiac disorders
20100-Cardiac disorders - Other specify
0.00%
0/66
1.0%
1/98 • Number of events 1
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
Investigations
24100-Creatinine increased
0.00%
0/66
1.0%
1/98 • Number of events 1
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
General disorders
24600-Death NOS
0.00%
0/66
5.1%
5/98 • Number of events 5
28.6%
2/7 • Number of events 2
0.00%
0/10
2.6%
2/78 • Number of events 2
3.3%
1/30 • Number of events 1
Metabolism and nutrition disorders
24700-Dehydration
0.00%
0/66
1.0%
1/98 • Number of events 1
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
Investigations
34000-Fibrinogen decreased
0.00%
0/66
1.0%
1/98 • Number of events 1
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
General disorders
37200-General disorders and administration site conditions
1.5%
1/66 • Number of events 1
0.00%
0/98
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
Cardiac disorders
39000-Heart failure
0.00%
0/66
1.0%
1/98 • Number of events 1
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
Metabolism and nutrition disorders
43100-Hypokalemia
0.00%
0/66
1.0%
1/98 • Number of events 1
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
Metabolism and nutrition disorders
43300-Hyponatremia
0.00%
0/66
1.0%
1/98 • Number of events 1
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
Metabolism and nutrition disorders
43500-Hypophosphatemia
0.00%
0/66
1.0%
1/98 • Number of events 1
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
Vascular disorders
43600-Hypotension
0.00%
0/66
1.0%
1/98 • Number of events 1
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
Respiratory, thoracic and mediastinal disorders
43900-Hypoxia
0.00%
0/66
2.0%
2/98 • Number of events 2
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
Gastrointestinal disorders
44200-Ileal obstruction
0.00%
0/66
1.0%
1/98 • Number of events 1
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
Infections and infestations
44800-Infections and infestations - Other specify
0.00%
0/66
0.00%
0/98
0.00%
0/7
0.00%
0/10
1.3%
1/78 • Number of events 3
0.00%
0/30
Cardiac disorders
51700-Left ventricular systolic dysfunction
0.00%
0/66
1.0%
1/98 • Number of events 1
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
Investigations
52600-Lipase increased
0.00%
0/66
1.0%
1/98 • Number of events 1
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
Infections and infestations
53100-Lung infection
0.00%
0/66
0.00%
0/98
0.00%
0/7
0.00%
0/10
1.3%
1/78 • Number of events 1
0.00%
0/30
General disorders
55700-Multi-organ failure
0.00%
0/66
0.00%
0/98
14.3%
1/7 • Number of events 1
0.00%
0/10
0.00%
0/78
0.00%
0/30
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
58000-Neoplasms benign malignant and unspecified (incl cy
0.00%
0/66
1.0%
1/98 • Number of events 1
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
Nervous system disorders
58100-Nervous system disorders - Other specify
0.00%
0/66
1.0%
1/98 • Number of events 1
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
General disorders
60600-Pain
0.00%
0/66
1.0%
1/98 • Number of events 1
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
Investigations
65800-Platelet count decreased
0.00%
0/66
1.0%
1/98 • Number of events 1
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
Respiratory, thoracic and mediastinal disorders
65900-Pleural effusion
0.00%
0/66
1.0%
1/98 • Number of events 1
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
Respiratory, thoracic and mediastinal disorders
66000-Pleural hemorrhage
0.00%
0/66
1.0%
1/98 • Number of events 1
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
Respiratory, thoracic and mediastinal disorders
66300-Pneumonitis
0.00%
0/66
2.0%
2/98 • Number of events 2
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
Respiratory, thoracic and mediastinal disorders
66400-Pneumothorax
0.00%
0/66
1.0%
1/98 • Number of events 1
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
Respiratory, thoracic and mediastinal disorders
68700-Pulmonary edema
0.00%
0/66
1.0%
1/98 • Number of events 1
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
Respiratory, thoracic and mediastinal disorders
69000-Pulmonary hypertension
0.00%
0/66
1.0%
1/98 • Number of events 1
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
Respiratory, thoracic and mediastinal disorders
71500-Respiratory failure
0.00%
0/66
2.0%
2/98 • Number of events 2
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
Infections and infestations
73700-Sepsis
0.00%
0/66
1.0%
1/98 • Number of events 2
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
General disorders
78300-Sudden death NOS
1.5%
1/66 • Number of events 1
0.00%
0/98
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
81200-Treatment related secondary malignancy
0.00%
0/66
1.0%
1/98 • Number of events 1
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
Gastrointestinal disorders
87900-Vomiting
0.00%
0/66
1.0%
1/98 • Number of events 1
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
Investigations
88200-Weight gain
0.00%
0/66
0.00%
0/98
14.3%
1/7 • Number of events 1
0.00%
0/10
0.00%
0/78
0.00%
0/30

Other adverse events

Other adverse events
Measure
Surgery
n=66 participants at risk
Surgery Only
UH-1
n=98 participants at risk
Cyclophosphamide/carboplatin/etoposide;vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT
Window/UH-1
n=7 participants at risk
Window therapy of vincristine/irinotecan; Cyclophosphamide/carboplatin/etoposide;vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT"
UH-2
n=10 participants at risk
Window therapy of vincristine/irinotecan;Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 36 weeks; XRT
Regimen I
n=78 participants at risk
Vincristine/doxorubicin/cyclophosphamide; cyclophosphamide/etoposide x25 weeks; XRT
Regimen DD-4A
n=30 participants at risk
Vincristine/dactinomycin/doxorubicin x25 weeks; XRT"
Gastrointestinal disorders
10100-Abdominal distension
0.00%
0/66
0.00%
0/98
28.6%
2/7 • Number of events 2
0.00%
0/10
0.00%
0/78
0.00%
0/30
Infections and infestations
10200-Abdominal infection
0.00%
0/66
0.00%
0/98
0.00%
0/7
10.0%
1/10 • Number of events 1
0.00%
0/78
0.00%
0/30
Gastrointestinal disorders
10300-Abdominal pain
0.00%
0/66
6.1%
6/98 • Number of events 6
14.3%
1/7 • Number of events 1
10.0%
1/10 • Number of events 1
0.00%
0/78
0.00%
0/30
Metabolism and nutrition disorders
10700-Acidosis
0.00%
0/66
3.1%
3/98 • Number of events 3
14.3%
1/7 • Number of events 1
0.00%
0/10
0.00%
0/78
0.00%
0/30
Renal and urinary disorders
11100-Acute kidney injury
0.00%
0/66
2.0%
2/98 • Number of events 2
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
Respiratory, thoracic and mediastinal disorders
11300-Adult respiratory distress syndrome
0.00%
0/66
1.0%
1/98 • Number of events 1
14.3%
1/7 • Number of events 1
0.00%
0/10
0.00%
0/78
0.00%
0/30
Psychiatric disorders
11400-Agitation
0.00%
0/66
0.00%
0/98
0.00%
0/7
10.0%
1/10 • Number of events 1
0.00%
0/78
0.00%
0/30
Investigations
11600-Alanine aminotransferase increased
0.00%
0/66
9.2%
9/98 • Number of events 10
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
Immune system disorders
13100-Anaphylaxis
0.00%
0/66
2.0%
2/98 • Number of events 2
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
Blood and lymphatic system disorders
13200-Anemia
0.00%
0/66
4.1%
4/98 • Number of events 6
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
Metabolism and nutrition disorders
13500-Anorexia
0.00%
0/66
20.4%
20/98 • Number of events 22
28.6%
2/7 • Number of events 3
20.0%
2/10 • Number of events 2
3.8%
3/78 • Number of events 4
0.00%
0/30
Respiratory, thoracic and mediastinal disorders
14100-Apnea
0.00%
0/66
0.00%
0/98
14.3%
1/7 • Number of events 1
0.00%
0/10
0.00%
0/78
0.00%
0/30
Gastrointestinal disorders
14900-Ascites
0.00%
0/66
0.00%
0/98
14.3%
1/7 • Number of events 1
0.00%
0/10
0.00%
0/78
0.00%
0/30
Investigations
15000-Aspartate aminotransferase increased
0.00%
0/66
8.2%
8/98 • Number of events 8
14.3%
1/7 • Number of events 1
10.0%
1/10 • Number of events 1
0.00%
0/78
0.00%
0/30
Respiratory, thoracic and mediastinal disorders
15400-Atelectasis
0.00%
0/66
1.0%
1/98 • Number of events 1
14.3%
1/7 • Number of events 1
0.00%
0/10
0.00%
0/78
0.00%
0/30
Blood and lymphatic system disorders
17200-Blood and lymphatic system disorders - Other specif
0.00%
0/66
1.0%
1/98 • Number of events 1
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
Investigations
17400-Blood bilirubin increased
0.00%
0/66
2.0%
2/98 • Number of events 2
14.3%
1/7 • Number of events 1
0.00%
0/10
0.00%
0/78
0.00%
0/30
Cardiac disorders
20000-Cardiac arrest
0.00%
0/66
0.00%
0/98
0.00%
0/7
10.0%
1/10 • Number of events 1
0.00%
0/78
0.00%
0/30
Infections and infestations
20500-Catheter related infection
0.00%
0/66
7.1%
7/98 • Number of events 7
14.3%
1/7 • Number of events 1
10.0%
1/10 • Number of events 1
0.00%
0/78
0.00%
0/30
Gastrointestinal disorders
22100-Colitis
0.00%
0/66
2.0%
2/98 • Number of events 2
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
Gastrointestinal disorders
22200-Colonic fistula
0.00%
0/66
1.0%
1/98 • Number of events 1
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
Gastrointestinal disorders
22300-Colonic hemorrhage
0.00%
0/66
0.00%
0/98
14.3%
1/7 • Number of events 1
0.00%
0/10
0.00%
0/78
0.00%
0/30
Investigations
24100-Creatinine increased
0.00%
0/66
3.1%
3/98 • Number of events 3
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
Renal and urinary disorders
24300-Cystitis noninfective
0.00%
0/66
1.0%
1/98 • Number of events 1
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
Metabolism and nutrition disorders
24700-Dehydration
0.00%
0/66
9.2%
9/98 • Number of events 10
0.00%
0/7
20.0%
2/10 • Number of events 2
0.00%
0/78
0.00%
0/30
Gastrointestinal disorders
25700-Diarrhea
0.00%
0/66
10.2%
10/98 • Number of events 11
14.3%
1/7 • Number of events 1
30.0%
3/10 • Number of events 3
0.00%
0/78
0.00%
0/30
Blood and lymphatic system disorders
25800-Disseminated intravascular coagulation
0.00%
0/66
1.0%
1/98 • Number of events 1
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
Gastrointestinal disorders
27600-Dysphagia
0.00%
0/66
2.0%
2/98 • Number of events 2
0.00%
0/7
10.0%
1/10 • Number of events 1
0.00%
0/78
0.00%
0/30
Respiratory, thoracic and mediastinal disorders
27800-Dyspnea
0.00%
0/66
0.00%
0/98
0.00%
0/7
20.0%
2/10 • Number of events 2
0.00%
0/78
0.00%
0/30
General disorders
28200-Edema face
0.00%
0/66
1.0%
1/98 • Number of events 1
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
Gastrointestinal disorders
29400-Enterocolitis
0.00%
0/66
1.0%
1/98 • Number of events 1
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
Infections and infestations
29500-Enterocolitis infectious
0.00%
0/66
4.1%
4/98 • Number of events 5
0.00%
0/7
10.0%
1/10 • Number of events 1
0.00%
0/78
0.00%
0/30
Respiratory, thoracic and mediastinal disorders
29700-Epistaxis
0.00%
0/66
1.0%
1/98 • Number of events 1
14.3%
1/7 • Number of events 1
0.00%
0/10
0.00%
0/78
0.00%
0/30
Gastrointestinal disorders
31200-Esophagitis
0.00%
0/66
1.0%
1/98 • Number of events 1
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
Nervous system disorders
32400-Facial nerve disorder
0.00%
0/66
1.0%
1/98 • Number of events 1
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
Blood and lymphatic system disorders
33300-Febrile neutropenia
0.00%
0/66
57.1%
56/98 • Number of events 86
42.9%
3/7 • Number of events 5
80.0%
8/10 • Number of events 12
5.1%
4/78 • Number of events 6
0.00%
0/30
General disorders
33900-Fever
0.00%
0/66
2.0%
2/98 • Number of events 2
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
Gastrointestinal disorders
36400-Gastritis
0.00%
0/66
0.00%
0/98
0.00%
0/7
10.0%
1/10 • Number of events 1
0.00%
0/78
0.00%
0/30
Gastrointestinal disorders
36700-Gastrointestinal disorders - Other specify
0.00%
0/66
1.0%
1/98 • Number of events 1
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
Investigations
37500-GGT increased
0.00%
0/66
1.0%
1/98 • Number of events 1
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
Ear and labyrinth disorders
38900-Hearing impaired
0.00%
0/66
0.00%
0/98
0.00%
0/7
0.00%
0/10
0.00%
0/78
3.3%
1/30 • Number of events 1
Vascular disorders
39100-Hematoma
0.00%
0/66
1.0%
1/98 • Number of events 1
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
Renal and urinary disorders
39300-Hematuria
0.00%
0/66
1.0%
1/98 • Number of events 1
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
Hepatobiliary disorders
40000-Hepatic failure
0.00%
0/66
1.0%
1/98 • Number of events 1
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
Hepatobiliary disorders
40600-Hepatobiliary disorders - Other specify
0.00%
0/66
1.0%
1/98 • Number of events 1
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
Nervous system disorders
41200-Hydrocephalus
0.00%
0/66
1.0%
1/98 • Number of events 1
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
Metabolism and nutrition disorders
41300-Hypercalcemia
0.00%
0/66
1.0%
1/98 • Number of events 1
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
Metabolism and nutrition disorders
41400-Hyperglycemia
0.00%
0/66
4.1%
4/98 • Number of events 5
14.3%
1/7 • Number of events 1
20.0%
2/10 • Number of events 5
0.00%
0/78
0.00%
0/30
Metabolism and nutrition disorders
41600-Hyperkalemia
0.00%
0/66
4.1%
4/98 • Number of events 4
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
Metabolism and nutrition disorders
41800-Hypernatremia
0.00%
0/66
0.00%
0/98
14.3%
1/7 • Number of events 1
0.00%
0/10
0.00%
0/78
0.00%
0/30
Vascular disorders
42100-Hypertension
0.00%
0/66
8.2%
8/98 • Number of events 9
14.3%
1/7 • Number of events 1
0.00%
0/10
0.00%
0/78
0.00%
0/30
Metabolism and nutrition disorders
42600-Hypoalbuminemia
0.00%
0/66
4.1%
4/98 • Number of events 4
28.6%
2/7 • Number of events 3
10.0%
1/10 • Number of events 1
0.00%
0/78
0.00%
0/30
Metabolism and nutrition disorders
42700-Hypocalcemia
0.00%
0/66
4.1%
4/98 • Number of events 4
14.3%
1/7 • Number of events 1
0.00%
0/10
0.00%
0/78
0.00%
0/30
Metabolism and nutrition disorders
42900-Hypoglycemia
0.00%
0/66
1.0%
1/98 • Number of events 1
0.00%
0/7
10.0%
1/10 • Number of events 2
0.00%
0/78
0.00%
0/30
Metabolism and nutrition disorders
43100-Hypokalemia
0.00%
0/66
14.3%
14/98 • Number of events 19
42.9%
3/7 • Number of events 4
10.0%
1/10 • Number of events 1
0.00%
0/78
0.00%
0/30
Metabolism and nutrition disorders
43200-Hypomagnesemia
0.00%
0/66
1.0%
1/98 • Number of events 1
14.3%
1/7 • Number of events 1
0.00%
0/10
0.00%
0/78
0.00%
0/30
Metabolism and nutrition disorders
43300-Hyponatremia
0.00%
0/66
8.2%
8/98 • Number of events 8
14.3%
1/7 • Number of events 1
20.0%
2/10 • Number of events 2
0.00%
0/78
0.00%
0/30
Metabolism and nutrition disorders
43500-Hypophosphatemia
0.00%
0/66
5.1%
5/98 • Number of events 7
0.00%
0/7
10.0%
1/10 • Number of events 1
0.00%
0/78
0.00%
0/30
Vascular disorders
43600-Hypotension
0.00%
0/66
8.2%
8/98 • Number of events 8
14.3%
1/7 • Number of events 1
0.00%
0/10
0.00%
0/78
0.00%
0/30
Respiratory, thoracic and mediastinal disorders
43900-Hypoxia
0.00%
0/66
6.1%
6/98 • Number of events 6
28.6%
2/7 • Number of events 3
10.0%
1/10 • Number of events 1
0.00%
0/78
0.00%
0/30
Infections and infestations
44800-Infections and infestations - Other specify
0.00%
0/66
44.9%
44/98 • Number of events 77
57.1%
4/7 • Number of events 4
40.0%
4/10 • Number of events 13
1.3%
1/78 • Number of events 3
0.00%
0/30
Gastrointestinal disorders
46300-Intra-abdominal hemorrhage
0.00%
0/66
0.00%
0/98
14.3%
1/7 • Number of events 1
0.00%
0/10
0.00%
0/78
0.00%
0/30
Investigations
48400-Investigations - Other specify
0.00%
0/66
1.0%
1/98 • Number of events 1
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
Cardiac disorders
51700-Left ventricular systolic dysfunction
0.00%
0/66
2.0%
2/98 • Number of events 2
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
Investigations
52600-Lipase increased
0.00%
0/66
2.0%
2/98 • Number of events 2
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
Infections and infestations
53100-Lung infection
0.00%
0/66
2.0%
2/98 • Number of events 2
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
Vascular disorders
53500-Lymphedema
0.00%
0/66
1.0%
1/98 • Number of events 1
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
Investigations
53700-Lymphocyte count decreased
0.00%
0/66
1.0%
1/98 • Number of events 1
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
Gastrointestinal disorders
53900-Malabsorption
0.00%
0/66
1.0%
1/98 • Number of events 1
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
Gastrointestinal disorders
55600-Mucositis oral
0.00%
0/66
9.2%
9/98 • Number of events 9
14.3%
1/7 • Number of events 1
10.0%
1/10 • Number of events 1
0.00%
0/78
0.00%
0/30
General disorders
55700-Multi-organ failure
0.00%
0/66
1.0%
1/98 • Number of events 1
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
Cardiac disorders
56900-Myocarditis
0.00%
0/66
1.0%
1/98 • Number of events 1
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
Gastrointestinal disorders
57600-Nausea
0.00%
0/66
5.1%
5/98 • Number of events 6
14.3%
1/7 • Number of events 1
0.00%
0/10
1.3%
1/78 • Number of events 1
0.00%
0/30
Nervous system disorders
58100-Nervous system disorders - Other specify
0.00%
0/66
0.00%
0/98
0.00%
0/7
0.00%
0/10
1.3%
1/78 • Number of events 1
0.00%
0/30
Investigations
58300-Neutrophil count decreased
0.00%
0/66
6.1%
6/98 • Number of events 8
0.00%
0/7
10.0%
1/10 • Number of events 1
2.6%
2/78 • Number of events 3
0.00%
0/30
Gastrointestinal disorders
59600-Oral hemorrhage
0.00%
0/66
0.00%
0/98
14.3%
1/7 • Number of events 1
0.00%
0/10
0.00%
0/78
0.00%
0/30
Gastrointestinal disorders
59700-Oral pain
0.00%
0/66
2.0%
2/98 • Number of events 2
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
Infections and infestations
60100-Otitis media
0.00%
0/66
2.0%
2/98 • Number of events 2
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
General disorders
60600-Pain
0.00%
0/66
1.0%
1/98 • Number of events 1
14.3%
1/7 • Number of events 1
0.00%
0/10
0.00%
0/78
0.00%
0/30
Musculoskeletal and connective tissue disorders
60700-Pain in extremity
0.00%
0/66
0.00%
0/98
0.00%
0/7
10.0%
1/10 • Number of events 1
0.00%
0/78
0.00%
0/30
Gastrointestinal disorders
61800-Pancreatitis
0.00%
0/66
1.0%
1/98 • Number of events 1
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
Infections and infestations
62500-Pelvic infection
0.00%
0/66
1.0%
1/98 • Number of events 1
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
Cardiac disorders
63100-Pericardial effusion
0.00%
0/66
1.0%
1/98 • Number of events 1
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
Nervous system disorders
63900-Peripheral motor neuropathy
0.00%
0/66
1.0%
1/98 • Number of events 1
0.00%
0/7
0.00%
0/10
1.3%
1/78 • Number of events 1
0.00%
0/30
Nervous system disorders
64100-Peripheral sensory neuropathy
0.00%
0/66
1.0%
1/98 • Number of events 1
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
Infections and infestations
64200-Peritoneal infection
0.00%
0/66
2.0%
2/98 • Number of events 2
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
Infections and infestations
65200-Pharyngitis
0.00%
0/66
0.00%
0/98
0.00%
0/7
10.0%
1/10 • Number of events 1
0.00%
0/78
0.00%
0/30
Respiratory, thoracic and mediastinal disorders
65300-Pharyngolaryngeal pain
0.00%
0/66
0.00%
0/98
0.00%
0/7
10.0%
1/10 • Number of events 1
0.00%
0/78
0.00%
0/30
Investigations
65800-Platelet count decreased
0.00%
0/66
5.1%
5/98 • Number of events 7
0.00%
0/7
10.0%
1/10 • Number of events 1
1.3%
1/78 • Number of events 1
0.00%
0/30
Respiratory, thoracic and mediastinal disorders
65900-Pleural effusion
0.00%
0/66
4.1%
4/98 • Number of events 4
0.00%
0/7
20.0%
2/10 • Number of events 3
0.00%
0/78
0.00%
0/30
Respiratory, thoracic and mediastinal disorders
66300-Pneumonitis
0.00%
0/66
2.0%
2/98 • Number of events 2
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
Hepatobiliary disorders
66500-Portal hypertension
0.00%
0/66
2.0%
2/98 • Number of events 2
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
Renal and urinary disorders
68300-Proteinuria
0.00%
0/66
1.0%
1/98 • Number of events 1
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
Respiratory, thoracic and mediastinal disorders
68700-Pulmonary edema
0.00%
0/66
0.00%
0/98
0.00%
0/7
10.0%
1/10 • Number of events 1
0.00%
0/78
0.00%
0/30
Respiratory, thoracic and mediastinal disorders
69000-Pulmonary hypertension
0.00%
0/66
1.0%
1/98 • Number of events 1
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
Skin and subcutaneous tissue disorders
69200-Purpura
0.00%
0/66
1.0%
1/98 • Number of events 1
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
Cardiac disorders
72700-Right ventricular dysfunction
0.00%
0/66
1.0%
1/98 • Number of events 1
0.00%
0/7
10.0%
1/10 • Number of events 1
0.00%
0/78
0.00%
0/30
Infections and infestations
73700-Sepsis
0.00%
0/66
2.0%
2/98 • Number of events 2
14.3%
1/7 • Number of events 1
0.00%
0/10
0.00%
0/78
0.00%
0/30
Investigations
73900-Serum amylase increased
0.00%
0/66
1.0%
1/98 • Number of events 1
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
Infections and infestations
74600-Sinusitis
0.00%
0/66
0.00%
0/98
0.00%
0/7
10.0%
1/10 • Number of events 1
0.00%
0/78
0.00%
0/30
Skin and subcutaneous tissue disorders
74700-Skin and subcutaneous tissue disorders - Other spec
0.00%
0/66
1.0%
1/98 • Number of events 1
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
Infections and infestations
75200-Skin infection
0.00%
0/66
2.0%
2/98 • Number of events 2
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
Gastrointestinal disorders
75700-Small intestinal obstruction
0.00%
0/66
1.0%
1/98 • Number of events 1
14.3%
1/7 • Number of events 1
0.00%
0/10
0.00%
0/78
0.00%
0/30
Infections and infestations
76000-Small intestine infection
0.00%
0/66
1.0%
1/98 • Number of events 1
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
Infections and infestations
76400-Soft tissue infection
0.00%
0/66
1.0%
1/98 • Number of events 1
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
Vascular disorders
79600-Thromboembolic event
0.00%
0/66
3.1%
3/98 • Number of events 4
0.00%
0/7
10.0%
1/10 • Number of events 1
0.00%
0/78
0.00%
0/30
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
81800-Tumor pain
0.00%
0/66
1.0%
1/98 • Number of events 1
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
Gastrointestinal disorders
81900-Typhlitis
0.00%
0/66
2.0%
2/98 • Number of events 2
14.3%
1/7 • Number of events 1
0.00%
0/10
0.00%
0/78
0.00%
0/30
Infections and infestations
82300-Upper respiratory infection
0.00%
0/66
3.1%
3/98 • Number of events 3
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
Infections and infestations
83100-Urinary tract infection
0.00%
0/66
4.1%
4/98 • Number of events 5
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
Investigations
83600-Urine output decreased
0.00%
0/66
1.0%
1/98 • Number of events 1
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
Injury, poisoning and procedural complications
86400-Vascular access complication
0.00%
0/66
1.0%
1/98 • Number of events 1
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
Gastrointestinal disorders
87900-Vomiting
0.00%
0/66
9.2%
9/98 • Number of events 9
28.6%
2/7 • Number of events 2
10.0%
1/10 • Number of events 1
1.3%
1/78 • Number of events 1
0.00%
0/30
Investigations
88300-Weight loss
0.00%
0/66
1.0%
1/98 • Number of events 2
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
Investigations
88500-White blood cell decreased
0.00%
0/66
4.1%
4/98 • Number of events 5
0.00%
0/7
0.00%
0/10
0.00%
0/78
0.00%
0/30
Infections and infestations
88900-Wound infection
0.00%
0/66
1.0%
1/98 • Number of events 1
14.3%
1/7 • Number of events 1
10.0%
1/10 • Number of events 1
0.00%
0/78
0.00%
0/30

Additional Information

Results Reporting Coordinator

Children's Oncology Group

Phone: 626-447-0064

Results disclosure agreements

  • Principal investigator is a sponsor employee Must obtain prior Sponsor approval.
  • Publication restrictions are in place

Restriction type: OTHER