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

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ClinicalTrials.gov Identifier: NCT00335556
Recruitment Status : Completed
First Posted : June 12, 2006
Results First Posted : June 14, 2017
Last Update Posted : July 21, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Childhood Renal Cell Carcinoma
Clear Cell Renal Cell Carcinoma
Clear Cell Sarcoma of the Kidney
Papillary Renal Cell Carcinoma
Rhabdoid Tumor of the Kidney
Stage I Renal Cell Cancer
Stage I Renal Wilms Tumor
Stage II Renal Cell Cancer
Stage II Renal Wilms Tumor
Stage III Renal Cell Cancer
Stage III Renal Wilms Tumor
Stage IV Renal Cell Cancer
Stage IV Renal Wilms Tumor
Interventions Drug: Doxorubicin Hydrochloride
Drug: Irinotecan Hydrochloride
Procedure: Conventional Surgery
Drug: Cyclophosphamide
Drug: Etoposide
Drug: Carboplatin
Biological: Dactinomycin
Drug: Vincristine Sulfate
Radiation: Radiation Therapy
Other: Laboratory Biomarker Analysis
Enrollment 291
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Surgery UH-1 Window/UH-1 UH-2 Regimen I Regimen DD-4A
Hide Arm/Group Description Surgery Only Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT. Window therapy of vincristine/irinotecan;Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT. Window therapy of vincristine/irinotecan;Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 36 weeks; XRT. Vincristine/doxorubicin/cyclophosphamide; cyclophosphamide/etoposide x25 weeks; XRT. Vincristine/dactinomycin/doxorubicin x25 weeks; XRT.
Period Title: Overall Study
Started 68 98 7 10 78 30
Completed 66 64 2 5 77 29
Not Completed 2 34 5 5 1 1
Reason Not Completed
Death             0             5             0             0             1             0
Lack of Efficacy             0             19             3             3             0             1
Physician Decision             0             6             2             1             0             0
Ineligible             2             0             0             0             0             0
Refusal of further protocol therapy             0             4             0             1             0             0
Arm/Group Title Surgery UH-1 Window/UH-1 UH-2 Regimen I Regimen DD-4A Total
Hide Arm/Group Description Surgery Only Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT. Window therapy of vincristine/irinotecan;Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT. Window therapy of vincristine/irinotecan;Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 36 weeks; XRT. Vincristine/doxorubicin/cyclophosphamide; cyclophosphamide/etoposide x25 weeks; XRT. Vincristine/dactinomycin/doxorubicin x25 weeks; XRT. Total of all reporting groups
Overall Number of Baseline Participants 68 98 7 10 78 30 291
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 68 participants 98 participants 7 participants 10 participants 78 participants 30 participants 291 participants
148.53  (51.74) 52.39  (40.09) 68.95  (97.64) 54.04  (19.71) 34.10  (31.10) 54.29  (32.72) 70.60  (60.50)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 68 participants 98 participants 7 participants 10 participants 78 participants 30 participants 291 participants
Female
28
  41.2%
55
  56.1%
5
  71.4%
7
  70.0%
31
  39.7%
11
  36.7%
137
  47.1%
Male
40
  58.8%
43
  43.9%
2
  28.6%
3
  30.0%
47
  60.3%
19
  63.3%
154
  52.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 68 participants 98 participants 7 participants 10 participants 78 participants 30 participants 291 participants
Hispanic or Latino
5
   7.4%
8
   8.2%
0
   0.0%
2
  20.0%
15
  19.2%
4
  13.3%
34
  11.7%
Not Hispanic or Latino
63
  92.6%
88
  89.8%
6
  85.7%
8
  80.0%
63
  80.8%
25
  83.3%
253
  86.9%
Unknown or Not Reported
0
   0.0%
2
   2.0%
1
  14.3%
0
   0.0%
0
   0.0%
1
   3.3%
4
   1.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 68 participants 98 participants 7 participants 10 participants 78 participants 30 participants 291 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   1.5%
1
   1.0%
0
   0.0%
0
   0.0%
3
   3.8%
0
   0.0%
5
   1.7%
Native Hawaiian or Other Pacific Islander
1
   1.5%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.3%
Black or African American
22
  32.4%
17
  17.3%
1
  14.3%
2
  20.0%
13
  16.7%
5
  16.7%
60
  20.6%
White
40
  58.8%
72
  73.5%
5
  71.4%
8
  80.0%
55
  70.5%
22
  73.3%
202
  69.4%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
4
   5.9%
8
   8.2%
1
  14.3%
0
   0.0%
7
   9.0%
3
  10.0%
23
   7.9%
1.Primary Outcome
Title Event-Free Survival of Patients With Diffuse Anaplastic Wilms' Tumor (DAWT)
Hide Description 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).
Time Frame 4 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Eligible patients with Stage II-IV DAWT.
Arm/Group Title UH-1 Window/UH-1 UH-2
Hide Arm/Group Description:
Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT.
Window therapy of vincristine/irinotecan;Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT.
Window therapy of vincristine/irinotecan;Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 36 weeks; XRT.
Overall Number of Participants Analyzed 52 4 10
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of 4-year OS
76.1
(62.5 to 89.6)
25.0
(0 to 67.4)
87.5
(64.6 to 100.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection UH-1, Window/UH-1, UH-2
Comments The event-free survival distributions of patients with Stage II-IV diffuse anaplastic Wilms' tumor on AREN0321 and NWTS-5 (NCT00002610) were compared using the log-rank test.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .0199
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Log Rank Test Statistic
Estimated Value 5.4190
Estimation Comments [Not Specified]
2.Primary Outcome
Title Long-term Survival of Patients With Stage I-IV Malignant Rhabdoid Tumors
Hide Description 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).
Time Frame 4 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Eligible patients with Stage I-IV rhabdoid tumor.
Arm/Group Title UH-1
Hide Arm/Group Description:
Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphamide; x 30 weeks; XRT.
Overall Number of Participants Analyzed 36
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of 4-year OS
38.9
(20.1 to 57.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection UH-1
Comments The overall survival distributions of patients with Stage I-IV malignant rhabdoid tumors on AREN0321 and National Wilms Tumor Study-5 -- Treatment of Relapsed Patients, A National Wilms Tumor Study Group Phase III Study (NCT00002610) were compared using the log-rank test.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .3478
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Log Rank Test Statistic
Estimated Value .8814
Estimation Comments [Not Specified]
3.Primary Outcome
Title Response Rate
Hide Description 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.
Time Frame Up to 2 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Combined Window/UH-1 and UH-2
Hide Arm/Group Description:
Combine window/UH-1 and UH-2 for response rate monitoring for window therapy.
Overall Number of Participants Analyzed 17
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
71
(49 to 92)
4.Primary Outcome
Title Event Free Survival Probability
Hide Description Event-free survival will be informally compared to that seem for similar patients treated on NWTS-5 (NCT00002610).
Time Frame 4 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Eligible patients with Stage I focal and diffuse anaplastic Wilms tumor.
Arm/Group Title Regimen DD-4A
Hide Arm/Group Description:
Vincristine/dactinomycin/doxorubicin x25 weeks; XRT.
Overall Number of Participants Analyzed 18
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percent Probability 4 Year EFS
100.0
(100.0 to 100.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Regimen DD-4A
Comments The event-free survival distributions of patients with Stage I focal and diffuse anaplastic Wilms tumors on AREN0321 and National Wilms Tumor Study-5 -- Treatment of Relapsed Patients, A National Wilms Tumor Study Group Phase III Study (NCT00002610) were compared using the log-rank test.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .0570
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Log Rank Test Statistic
Estimated Value 3.6216
Estimation Comments [Not Specified]
5.Primary Outcome
Title Toxicity Rate
Hide Description Percentage of participants with Grade 4 cardiac toxicities, Grade 4 Sinusoidal Obstruction Syndrome (SOS), and treatment-related deaths determined using CTCAE v4.
Time Frame Up to 4 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Eligible patients treated after Amendment 3A for arms UH-1, UH-2, and Window/UH-1.
Arm/Group Title Combined UH-2, UH-1, Window/UH-1
Hide Arm/Group Description:
Combined UH-1, UH-2, and Window/UH-1 for revised-UH toxicity monitoring
Overall Number of Participants Analyzed 61
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of patients
Cardiac toxicities
4.9
(0 to 10.3)
Treatment-related deaths
4.9
(0 to 10.3)
Sinusoidal Obstruction Syndrome
0
(0 to 0)
6.Secondary Outcome
Title Number of Patients With INI1 Mutations in Renal and Extrarenal Malignant Rhabdoid Tumor by Fluorescent in Situ Hybridization
Hide Description [Not Specified]
Time Frame At baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Eligible patients with reported INI1 mutation data.
Arm/Group Title UH-1 Window/UH-1
Hide Arm/Group Description:
Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT.
Window therapy of vincristine/irinotecan;Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT.
Overall Number of Participants Analyzed 26 1
Measure Type: Number
Unit of Measure: Count participants
23 1
7.Secondary Outcome
Title Frequency of TP53 Mutations
Hide Description [Not Specified]
Time Frame At baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title UH-1 Window/UH-1 UH-2 Regimen DD-4A
Hide Arm/Group Description:
Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide;x 30 weeks; XRT.
Window therapy of vincristine/irinotecan;Cyclophosphamide/carboplatin/etoposide;vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT.
Window therapy of vincristine/irinotecan;Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 36 weeks; XRT
Vincristine/dactinomycin/doxorubicin x25 weeks; XRT
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Surgery UH-1 Window/UH-1 UH-2 Regimen I Regimen DD-4A
Hide Arm/Group Description Surgery Only Cyclophosphamide/carboplatin/etoposide;vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT Window therapy of vincristine/irinotecan; Cyclophosphamide/carboplatin/etoposide;vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT" Window therapy of vincristine/irinotecan;Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 36 weeks; XRT Vincristine/doxorubicin/cyclophosphamide; cyclophosphamide/etoposide x25 weeks; XRT Vincristine/dactinomycin/doxorubicin x25 weeks; XRT"
All-Cause Mortality
Surgery UH-1 Window/UH-1 UH-2 Regimen I Regimen DD-4A
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Surgery UH-1 Window/UH-1 UH-2 Regimen I Regimen DD-4A
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/66 (3.03%)      19/98 (19.39%)      3/7 (42.86%)      0/10 (0.00%)      3/78 (3.85%)      1/30 (3.33%)    
Cardiac disorders             
20000-Cardiac arrest  0/66 (0.00%)  0 1/98 (1.02%)  1 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
20100-Cardiac disorders - Other specify  0/66 (0.00%)  0 1/98 (1.02%)  1 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
39000-Heart failure  0/66 (0.00%)  0 1/98 (1.02%)  1 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
51700-Left ventricular systolic dysfunction  0/66 (0.00%)  0 1/98 (1.02%)  1 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
Gastrointestinal disorders             
10300-Abdominal pain  0/66 (0.00%)  0 0/98 (0.00%)  0 1/7 (14.29%)  1 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
14900-Ascites  0/66 (0.00%)  0 2/98 (2.04%)  2 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
44200-Ileal obstruction  0/66 (0.00%)  0 1/98 (1.02%)  1 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
87900-Vomiting  0/66 (0.00%)  0 1/98 (1.02%)  1 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
General disorders             
24600-Death NOS  0/66 (0.00%)  0 5/98 (5.10%)  5 2/7 (28.57%)  2 0/10 (0.00%)  0 2/78 (2.56%)  2 1/30 (3.33%)  1
37200-General disorders and administration site conditions  1/66 (1.52%)  1 0/98 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
55700-Multi-organ failure  0/66 (0.00%)  0 0/98 (0.00%)  0 1/7 (14.29%)  1 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
60600-Pain  0/66 (0.00%)  0 1/98 (1.02%)  1 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
78300-Sudden death NOS  1/66 (1.52%)  1 0/98 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
Infections and infestations             
44800-Infections and infestations - Other specify  0/66 (0.00%)  0 0/98 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 1/78 (1.28%)  3 0/30 (0.00%)  0
53100-Lung infection  0/66 (0.00%)  0 0/98 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 1/78 (1.28%)  1 0/30 (0.00%)  0
73700-Sepsis  0/66 (0.00%)  0 1/98 (1.02%)  2 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
Investigations             
11600-Alanine aminotransferase increased  0/66 (0.00%)  0 1/98 (1.02%)  1 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
15000-Aspartate aminotransferase increased  0/66 (0.00%)  0 1/98 (1.02%)  1 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
17400-Blood bilirubin increased  0/66 (0.00%)  0 2/98 (2.04%)  2 1/7 (14.29%)  1 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
24100-Creatinine increased  0/66 (0.00%)  0 1/98 (1.02%)  1 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
34000-Fibrinogen decreased  0/66 (0.00%)  0 1/98 (1.02%)  1 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
52600-Lipase increased  0/66 (0.00%)  0 1/98 (1.02%)  1 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
65800-Platelet count decreased  0/66 (0.00%)  0 1/98 (1.02%)  1 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
88200-Weight gain  0/66 (0.00%)  0 0/98 (0.00%)  0 1/7 (14.29%)  1 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
Metabolism and nutrition disorders             
24700-Dehydration  0/66 (0.00%)  0 1/98 (1.02%)  1 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
43100-Hypokalemia  0/66 (0.00%)  0 1/98 (1.02%)  1 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
43300-Hyponatremia  0/66 (0.00%)  0 1/98 (1.02%)  1 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
43500-Hypophosphatemia  0/66 (0.00%)  0 1/98 (1.02%)  1 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
58000-Neoplasms benign malignant and unspecified (incl cy  0/66 (0.00%)  0 1/98 (1.02%)  1 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
81200-Treatment related secondary malignancy  0/66 (0.00%)  0 1/98 (1.02%)  1 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
Nervous system disorders             
58100-Nervous system disorders - Other specify  0/66 (0.00%)  0 1/98 (1.02%)  1 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
Renal and urinary disorders             
11100-Acute kidney injury  0/66 (0.00%)  0 1/98 (1.02%)  1 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
Respiratory, thoracic and mediastinal disorders             
11300-Adult respiratory distress syndrome  0/66 (0.00%)  0 2/98 (2.04%)  2 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
19200-Bronchopulmonary hemorrhage  0/66 (0.00%)  0 1/98 (1.02%)  1 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
43900-Hypoxia  0/66 (0.00%)  0 2/98 (2.04%)  2 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
65900-Pleural effusion  0/66 (0.00%)  0 1/98 (1.02%)  1 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
66000-Pleural hemorrhage  0/66 (0.00%)  0 1/98 (1.02%)  1 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
66300-Pneumonitis  0/66 (0.00%)  0 2/98 (2.04%)  2 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
66400-Pneumothorax  0/66 (0.00%)  0 1/98 (1.02%)  1 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
68700-Pulmonary edema  0/66 (0.00%)  0 1/98 (1.02%)  1 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
69000-Pulmonary hypertension  0/66 (0.00%)  0 1/98 (1.02%)  1 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
71500-Respiratory failure  0/66 (0.00%)  0 2/98 (2.04%)  2 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
Vascular disorders             
43600-Hypotension  0/66 (0.00%)  0 1/98 (1.02%)  1 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
1
Term from vocabulary, CTCv4
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Surgery UH-1 Window/UH-1 UH-2 Regimen I Regimen DD-4A
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/66 (0.00%)      81/98 (82.65%)      5/7 (71.43%)      9/10 (90.00%)      7/78 (8.97%)      1/30 (3.33%)    
Blood and lymphatic system disorders             
13200-Anemia  0/66 (0.00%)  0 4/98 (4.08%)  6 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
17200-Blood and lymphatic system disorders - Other specif  0/66 (0.00%)  0 1/98 (1.02%)  1 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
25800-Disseminated intravascular coagulation  0/66 (0.00%)  0 1/98 (1.02%)  1 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
33300-Febrile neutropenia  0/66 (0.00%)  0 56/98 (57.14%)  86 3/7 (42.86%)  5 8/10 (80.00%)  12 4/78 (5.13%)  6 0/30 (0.00%)  0
Cardiac disorders             
20000-Cardiac arrest  0/66 (0.00%)  0 0/98 (0.00%)  0 0/7 (0.00%)  0 1/10 (10.00%)  1 0/78 (0.00%)  0 0/30 (0.00%)  0
51700-Left ventricular systolic dysfunction  0/66 (0.00%)  0 2/98 (2.04%)  2 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
56900-Myocarditis  0/66 (0.00%)  0 1/98 (1.02%)  1 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
63100-Pericardial effusion  0/66 (0.00%)  0 1/98 (1.02%)  1 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
72700-Right ventricular dysfunction  0/66 (0.00%)  0 1/98 (1.02%)  1 0/7 (0.00%)  0 1/10 (10.00%)  1 0/78 (0.00%)  0 0/30 (0.00%)  0
Ear and labyrinth disorders             
38900-Hearing impaired  0/66 (0.00%)  0 0/98 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 1/30 (3.33%)  1
Gastrointestinal disorders             
10100-Abdominal distension  0/66 (0.00%)  0 0/98 (0.00%)  0 2/7 (28.57%)  2 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
10300-Abdominal pain  0/66 (0.00%)  0 6/98 (6.12%)  6 1/7 (14.29%)  1 1/10 (10.00%)  1 0/78 (0.00%)  0 0/30 (0.00%)  0
14900-Ascites  0/66 (0.00%)  0 0/98 (0.00%)  0 1/7 (14.29%)  1 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
22100-Colitis  0/66 (0.00%)  0 2/98 (2.04%)  2 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
22200-Colonic fistula  0/66 (0.00%)  0 1/98 (1.02%)  1 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
22300-Colonic hemorrhage  0/66 (0.00%)  0 0/98 (0.00%)  0 1/7 (14.29%)  1 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
25700-Diarrhea  0/66 (0.00%)  0 10/98 (10.20%)  11 1/7 (14.29%)  1 3/10 (30.00%)  3 0/78 (0.00%)  0 0/30 (0.00%)  0
27600-Dysphagia  0/66 (0.00%)  0 2/98 (2.04%)  2 0/7 (0.00%)  0 1/10 (10.00%)  1 0/78 (0.00%)  0 0/30 (0.00%)  0
29400-Enterocolitis  0/66 (0.00%)  0 1/98 (1.02%)  1 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
31200-Esophagitis  0/66 (0.00%)  0 1/98 (1.02%)  1 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
36400-Gastritis  0/66 (0.00%)  0 0/98 (0.00%)  0 0/7 (0.00%)  0 1/10 (10.00%)  1 0/78 (0.00%)  0 0/30 (0.00%)  0
36700-Gastrointestinal disorders - Other specify  0/66 (0.00%)  0 1/98 (1.02%)  1 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
46300-Intra-abdominal hemorrhage  0/66 (0.00%)  0 0/98 (0.00%)  0 1/7 (14.29%)  1 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
53900-Malabsorption  0/66 (0.00%)  0 1/98 (1.02%)  1 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
55600-Mucositis oral  0/66 (0.00%)  0 9/98 (9.18%)  9 1/7 (14.29%)  1 1/10 (10.00%)  1 0/78 (0.00%)  0 0/30 (0.00%)  0
57600-Nausea  0/66 (0.00%)  0 5/98 (5.10%)  6 1/7 (14.29%)  1 0/10 (0.00%)  0 1/78 (1.28%)  1 0/30 (0.00%)  0
59600-Oral hemorrhage  0/66 (0.00%)  0 0/98 (0.00%)  0 1/7 (14.29%)  1 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
59700-Oral pain  0/66 (0.00%)  0 2/98 (2.04%)  2 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
61800-Pancreatitis  0/66 (0.00%)  0 1/98 (1.02%)  1 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
75700-Small intestinal obstruction  0/66 (0.00%)  0 1/98 (1.02%)  1 1/7 (14.29%)  1 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
81900-Typhlitis  0/66 (0.00%)  0 2/98 (2.04%)  2 1/7 (14.29%)  1 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
87900-Vomiting  0/66 (0.00%)  0 9/98 (9.18%)  9 2/7 (28.57%)  2 1/10 (10.00%)  1 1/78 (1.28%)  1 0/30 (0.00%)  0
General disorders             
28200-Edema face  0/66 (0.00%)  0 1/98 (1.02%)  1 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
33900-Fever  0/66 (0.00%)  0 2/98 (2.04%)  2 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
55700-Multi-organ failure  0/66 (0.00%)  0 1/98 (1.02%)  1 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
60600-Pain  0/66 (0.00%)  0 1/98 (1.02%)  1 1/7 (14.29%)  1 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
Hepatobiliary disorders             
40000-Hepatic failure  0/66 (0.00%)  0 1/98 (1.02%)  1 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
40600-Hepatobiliary disorders - Other specify  0/66 (0.00%)  0 1/98 (1.02%)  1 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
66500-Portal hypertension  0/66 (0.00%)  0 2/98 (2.04%)  2 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
Immune system disorders             
13100-Anaphylaxis  0/66 (0.00%)  0 2/98 (2.04%)  2 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
Infections and infestations             
10200-Abdominal infection  0/66 (0.00%)  0 0/98 (0.00%)  0 0/7 (0.00%)  0 1/10 (10.00%)  1 0/78 (0.00%)  0 0/30 (0.00%)  0
20500-Catheter related infection  0/66 (0.00%)  0 7/98 (7.14%)  7 1/7 (14.29%)  1 1/10 (10.00%)  1 0/78 (0.00%)  0 0/30 (0.00%)  0
29500-Enterocolitis infectious  0/66 (0.00%)  0 4/98 (4.08%)  5 0/7 (0.00%)  0 1/10 (10.00%)  1 0/78 (0.00%)  0 0/30 (0.00%)  0
44800-Infections and infestations - Other specify  0/66 (0.00%)  0 44/98 (44.90%)  77 4/7 (57.14%)  4 4/10 (40.00%)  13 1/78 (1.28%)  3 0/30 (0.00%)  0
53100-Lung infection  0/66 (0.00%)  0 2/98 (2.04%)  2 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
60100-Otitis media  0/66 (0.00%)  0 2/98 (2.04%)  2 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
62500-Pelvic infection  0/66 (0.00%)  0 1/98 (1.02%)  1 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
64200-Peritoneal infection  0/66 (0.00%)  0 2/98 (2.04%)  2 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
65200-Pharyngitis  0/66 (0.00%)  0 0/98 (0.00%)  0 0/7 (0.00%)  0 1/10 (10.00%)  1 0/78 (0.00%)  0 0/30 (0.00%)  0
73700-Sepsis  0/66 (0.00%)  0 2/98 (2.04%)  2 1/7 (14.29%)  1 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
74600-Sinusitis  0/66 (0.00%)  0 0/98 (0.00%)  0 0/7 (0.00%)  0 1/10 (10.00%)  1 0/78 (0.00%)  0 0/30 (0.00%)  0
75200-Skin infection  0/66 (0.00%)  0 2/98 (2.04%)  2 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
76000-Small intestine infection  0/66 (0.00%)  0 1/98 (1.02%)  1 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
76400-Soft tissue infection  0/66 (0.00%)  0 1/98 (1.02%)  1 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
82300-Upper respiratory infection  0/66 (0.00%)  0 3/98 (3.06%)  3 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
83100-Urinary tract infection  0/66 (0.00%)  0 4/98 (4.08%)  5 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
88900-Wound infection  0/66 (0.00%)  0 1/98 (1.02%)  1 1/7 (14.29%)  1 1/10 (10.00%)  1 0/78 (0.00%)  0 0/30 (0.00%)  0
Injury, poisoning and procedural complications             
86400-Vascular access complication  0/66 (0.00%)  0 1/98 (1.02%)  1 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
Investigations             
11600-Alanine aminotransferase increased  0/66 (0.00%)  0 9/98 (9.18%)  10 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
15000-Aspartate aminotransferase increased  0/66 (0.00%)  0 8/98 (8.16%)  8 1/7 (14.29%)  1 1/10 (10.00%)  1 0/78 (0.00%)  0 0/30 (0.00%)  0
17400-Blood bilirubin increased  0/66 (0.00%)  0 2/98 (2.04%)  2 1/7 (14.29%)  1 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
24100-Creatinine increased  0/66 (0.00%)  0 3/98 (3.06%)  3 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
37500-GGT increased  0/66 (0.00%)  0 1/98 (1.02%)  1 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
48400-Investigations - Other specify  0/66 (0.00%)  0 1/98 (1.02%)  1 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
52600-Lipase increased  0/66 (0.00%)  0 2/98 (2.04%)  2 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
53700-Lymphocyte count decreased  0/66 (0.00%)  0 1/98 (1.02%)  1 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
58300-Neutrophil count decreased  0/66 (0.00%)  0 6/98 (6.12%)  8 0/7 (0.00%)  0 1/10 (10.00%)  1 2/78 (2.56%)  3 0/30 (0.00%)  0
65800-Platelet count decreased  0/66 (0.00%)  0 5/98 (5.10%)  7 0/7 (0.00%)  0 1/10 (10.00%)  1 1/78 (1.28%)  1 0/30 (0.00%)  0
73900-Serum amylase increased  0/66 (0.00%)  0 1/98 (1.02%)  1 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
83600-Urine output decreased  0/66 (0.00%)  0 1/98 (1.02%)  1 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
88300-Weight loss  0/66 (0.00%)  0 1/98 (1.02%)  2 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
88500-White blood cell decreased  0/66 (0.00%)  0 4/98 (4.08%)  5 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
Metabolism and nutrition disorders             
10700-Acidosis  0/66 (0.00%)  0 3/98 (3.06%)  3 1/7 (14.29%)  1 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
13500-Anorexia  0/66 (0.00%)  0 20/98 (20.41%)  22 2/7 (28.57%)  3 2/10 (20.00%)  2 3/78 (3.85%)  4 0/30 (0.00%)  0
24700-Dehydration  0/66 (0.00%)  0 9/98 (9.18%)  10 0/7 (0.00%)  0 2/10 (20.00%)  2 0/78 (0.00%)  0 0/30 (0.00%)  0
41300-Hypercalcemia  0/66 (0.00%)  0 1/98 (1.02%)  1 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
41400-Hyperglycemia  0/66 (0.00%)  0 4/98 (4.08%)  5 1/7 (14.29%)  1 2/10 (20.00%)  5 0/78 (0.00%)  0 0/30 (0.00%)  0
41600-Hyperkalemia  0/66 (0.00%)  0 4/98 (4.08%)  4 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
41800-Hypernatremia  0/66 (0.00%)  0 0/98 (0.00%)  0 1/7 (14.29%)  1 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
42600-Hypoalbuminemia  0/66 (0.00%)  0 4/98 (4.08%)  4 2/7 (28.57%)  3 1/10 (10.00%)  1 0/78 (0.00%)  0 0/30 (0.00%)  0
42700-Hypocalcemia  0/66 (0.00%)  0 4/98 (4.08%)  4 1/7 (14.29%)  1 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
42900-Hypoglycemia  0/66 (0.00%)  0 1/98 (1.02%)  1 0/7 (0.00%)  0 1/10 (10.00%)  2 0/78 (0.00%)  0 0/30 (0.00%)  0
43100-Hypokalemia  0/66 (0.00%)  0 14/98 (14.29%)  19 3/7 (42.86%)  4 1/10 (10.00%)  1 0/78 (0.00%)  0 0/30 (0.00%)  0
43200-Hypomagnesemia  0/66 (0.00%)  0 1/98 (1.02%)  1 1/7 (14.29%)  1 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
43300-Hyponatremia  0/66 (0.00%)  0 8/98 (8.16%)  8 1/7 (14.29%)  1 2/10 (20.00%)  2 0/78 (0.00%)  0 0/30 (0.00%)  0
43500-Hypophosphatemia  0/66 (0.00%)  0 5/98 (5.10%)  7 0/7 (0.00%)  0 1/10 (10.00%)  1 0/78 (0.00%)  0 0/30 (0.00%)  0
Musculoskeletal and connective tissue disorders             
60700-Pain in extremity  0/66 (0.00%)  0 0/98 (0.00%)  0 0/7 (0.00%)  0 1/10 (10.00%)  1 0/78 (0.00%)  0 0/30 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
81800-Tumor pain  0/66 (0.00%)  0 1/98 (1.02%)  1 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
Nervous system disorders             
32400-Facial nerve disorder  0/66 (0.00%)  0 1/98 (1.02%)  1 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
41200-Hydrocephalus  0/66 (0.00%)  0 1/98 (1.02%)  1 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
58100-Nervous system disorders - Other specify  0/66 (0.00%)  0 0/98 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 1/78 (1.28%)  1 0/30 (0.00%)  0
63900-Peripheral motor neuropathy  0/66 (0.00%)  0 1/98 (1.02%)  1 0/7 (0.00%)  0 0/10 (0.00%)  0 1/78 (1.28%)  1 0/30 (0.00%)  0
64100-Peripheral sensory neuropathy  0/66 (0.00%)  0 1/98 (1.02%)  1 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
Psychiatric disorders             
11400-Agitation  0/66 (0.00%)  0 0/98 (0.00%)  0 0/7 (0.00%)  0 1/10 (10.00%)  1 0/78 (0.00%)  0 0/30 (0.00%)  0
Renal and urinary disorders             
11100-Acute kidney injury  0/66 (0.00%)  0 2/98 (2.04%)  2 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
24300-Cystitis noninfective  0/66 (0.00%)  0 1/98 (1.02%)  1 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
39300-Hematuria  0/66 (0.00%)  0 1/98 (1.02%)  1 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
68300-Proteinuria  0/66 (0.00%)  0 1/98 (1.02%)  1 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
Respiratory, thoracic and mediastinal disorders             
11300-Adult respiratory distress syndrome  0/66 (0.00%)  0 1/98 (1.02%)  1 1/7 (14.29%)  1 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
14100-Apnea  0/66 (0.00%)  0 0/98 (0.00%)  0 1/7 (14.29%)  1 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
15400-Atelectasis  0/66 (0.00%)  0 1/98 (1.02%)  1 1/7 (14.29%)  1 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
27800-Dyspnea  0/66 (0.00%)  0 0/98 (0.00%)  0 0/7 (0.00%)  0 2/10 (20.00%)  2 0/78 (0.00%)  0 0/30 (0.00%)  0
29700-Epistaxis  0/66 (0.00%)  0 1/98 (1.02%)  1 1/7 (14.29%)  1 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
43900-Hypoxia  0/66 (0.00%)  0 6/98 (6.12%)  6 2/7 (28.57%)  3 1/10 (10.00%)  1 0/78 (0.00%)  0 0/30 (0.00%)  0
65300-Pharyngolaryngeal pain  0/66 (0.00%)  0 0/98 (0.00%)  0 0/7 (0.00%)  0 1/10 (10.00%)  1 0/78 (0.00%)  0 0/30 (0.00%)  0
65900-Pleural effusion  0/66 (0.00%)  0 4/98 (4.08%)  4 0/7 (0.00%)  0 2/10 (20.00%)  3 0/78 (0.00%)  0 0/30 (0.00%)  0
66300-Pneumonitis  0/66 (0.00%)  0 2/98 (2.04%)  2 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
68700-Pulmonary edema  0/66 (0.00%)  0 0/98 (0.00%)  0 0/7 (0.00%)  0 1/10 (10.00%)  1 0/78 (0.00%)  0 0/30 (0.00%)  0
69000-Pulmonary hypertension  0/66 (0.00%)  0 1/98 (1.02%)  1 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
Skin and subcutaneous tissue disorders             
69200-Purpura  0/66 (0.00%)  0 1/98 (1.02%)  1 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
74700-Skin and subcutaneous tissue disorders - Other spec  0/66 (0.00%)  0 1/98 (1.02%)  1 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
Vascular disorders             
39100-Hematoma  0/66 (0.00%)  0 1/98 (1.02%)  1 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
42100-Hypertension  0/66 (0.00%)  0 8/98 (8.16%)  9 1/7 (14.29%)  1 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
43600-Hypotension  0/66 (0.00%)  0 8/98 (8.16%)  8 1/7 (14.29%)  1 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
53500-Lymphedema  0/66 (0.00%)  0 1/98 (1.02%)  1 0/7 (0.00%)  0 0/10 (0.00%)  0 0/78 (0.00%)  0 0/30 (0.00%)  0
79600-Thromboembolic event  0/66 (0.00%)  0 3/98 (3.06%)  4 0/7 (0.00%)  0 1/10 (10.00%)  1 0/78 (0.00%)  0 0/30 (0.00%)  0
1
Term from vocabulary, CTCv4
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Must obtain prior Sponsor approval.
Results Point of Contact
Name/Title: Results Reporting Coordinator
Organization: Children's Oncology Group
Phone: 626-447-0064
Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00335556     History of Changes
Other Study ID Numbers: AREN0321
NCI-2009-00414 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
COG-AREN0321 ( Other Identifier: Children's Oncology Group )
CDR0000472893 ( Other Identifier: ClinicalTrials.gov )
AREN0321 ( Other Identifier: Children's Oncology Group )
AREN0321 ( Other Identifier: CTEP )
U10CA098543 ( U.S. NIH Grant/Contract )
First Submitted: June 8, 2006
First Posted: June 12, 2006
Results First Submitted: November 28, 2016
Results First Posted: June 14, 2017
Last Update Posted: July 21, 2017