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Trial record 7 of 7 for:    stem cell kidney | ( Map: Switzerland )

Comparing Two Different Myeloablation Therapies in Treating Young Patients Who Are Undergoing a Stem Cell Transplant for High-Risk Neuroblastoma

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ClinicalTrials.gov Identifier: NCT00567567
Recruitment Status : Completed
First Posted : December 5, 2007
Results First Posted : June 27, 2017
Last Update Posted : May 1, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Localized Resectable Neuroblastoma
Localized Unresectable Neuroblastoma
Recurrent Neuroblastoma
Regional Neuroblastoma
Stage 4 Neuroblastoma
Stage 4S Neuroblastoma
Interventions Procedure: Autologous Hematopoietic Stem Cell Transplantation
Drug: Carboplatin
Drug: Cisplatin
Drug: Cyclophosphamide
Drug: Doxorubicin Hydrochloride
Drug: Etoposide
Radiation: External Beam Radiation Therapy
Biological: Filgrastim
Drug: Isotretinoin
Other: Laboratory Biomarker Analysis
Drug: Melphalan
Procedure: Peripheral Blood Stem Cell Transplantation
Other: Pharmacological Study
Drug: Thiotepa
Drug: Topotecan Hydrochloride
Drug: Vincristine Sulfate Liposome
Enrollment 630
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Single HST (CEM) Tandem HST (CEM), Randomly Assigned Not Assigned
Hide Arm/Group Description Induction therapy + single myeloablative consolidation Induction therapy + tandem myeloablative consolidation Patients that either failed during Induction therapy or refused randomization
Period Title: Overall Study
Started 210 176 279
Completed 58 42 1
Not Completed 152 134 278
Reason Not Completed
Adverse Event             0             2             5
Death             8             1             5
Lack of Efficacy             16             17             48
Lost to Follow-up             0             0             1
Physician Decision             16             18             84
Withdrawal by Subject             0             0             2
Ineligible             4             0             9
Refusal by patient/parent/guardian             9             16             122
Enrolled another COG therapeutic study             99             80             0
Unable adequate stem cell for transplant             0             0             2
Arm/Group Title Single HST (CEM) Tandem HST (CEM), Randomly Assigned Not Assigned Total
Hide Arm/Group Description Induction therapy + single myeloablative consolidation Induction therapy + tandem myeloablative consolidation Patients that either failed during Induction therapy or refused randomization Total of all reporting groups
Overall Number of Baseline Participants 210 176 279 665
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 210 participants 176 participants 279 participants 665 participants
<=18 years
208
  99.0%
176
 100.0%
277
  99.3%
661
  99.4%
Between 18 and 65 years
2
   1.0%
0
   0.0%
2
   0.7%
4
   0.6%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 210 participants 176 participants 279 participants 665 participants
3.2  (2.9) 2.9  (2.4) 3.4  (2.8) 3.2  (2.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 210 participants 176 participants 279 participants 665 participants
Female
95
  45.2%
78
  44.3%
118
  42.3%
291
  43.8%
Male
115
  54.8%
98
  55.7%
161
  57.7%
374
  56.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 210 participants 176 participants 279 participants 665 participants
Hispanic or Latino
22
  10.5%
26
  14.8%
30
  10.8%
78
  11.7%
Not Hispanic or Latino
181
  86.2%
145
  82.4%
233
  83.5%
559
  84.1%
Unknown or Not Reported
7
   3.3%
5
   2.8%
16
   5.7%
28
   4.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 210 participants 176 participants 279 participants 665 participants
American Indian or Alaska Native
1
   0.5%
0
   0.0%
0
   0.0%
1
   0.2%
Asian
8
   3.8%
5
   2.8%
10
   3.6%
23
   3.5%
Native Hawaiian or Other Pacific Islander
1
   0.5%
0
   0.0%
3
   1.1%
4
   0.6%
Black or African American
23
  11.0%
18
  10.2%
40
  14.3%
81
  12.2%
White
157
  74.8%
132
  75.0%
203
  72.8%
492
  74.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
20
   9.5%
21
  11.9%
23
   8.2%
64
   9.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 210 participants 176 participants 279 participants 665 participants
New Zealand 3 1 3 7
Canada 19 21 23 63
United States 176 146 243 565
Australia 11 8 10 29
Switzerland 1 0 0 1
1.Primary Outcome
Title Event-free Survival Rate
Hide Description Comparison of EFS curves, starting from the time of randomization, by treatment group (single CEM vs. tandem CEM)
Time Frame Three years, from time of randomization
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible, randomized patients.
Arm/Group Title Single HST (CEM) Tandem HST (CEM), Randomly Assigned
Hide Arm/Group Description:
Induction therapy + single myeloablative consolidation
Induction therapy + tandem myeloablative consolidation
Overall Number of Participants Analyzed 179 176
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percent probability
48.8
(41.1 to 56.5)
61.8
(53.8 to 69.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Single HST (CEM), Tandem HST (CEM), Randomly Assigned
Comments The event-free survival distributions of patients randomized to Regimen A - Single HST (CEM) and randomized to Regimen B - Tandem HST (CEM) were compared using the log-rank test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0082
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Log Rank Test Statistic
Estimated Value 6.9883
Estimation Comments [Not Specified]
2.Primary Outcome
Title Incidence Rate of Local Recurrence
Hide Description Cumulative incidence rate of local recurrence comparison between ANBL0532 patients randomized or assigned to receive single CEM transplant and boost radiation versus the historical A3973 patients who were transplanted and received boost radiation.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients randomized or assigned to the single HST (CEM) treatment arm who also received boost radiation.
Arm/Group Title Single HST (CEM)
Hide Arm/Group Description:
Induction therapy + single myeloablative consolidation
Overall Number of Participants Analyzed 77
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage 3-year cumulative incidence
15.7
(7.5 to 23.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Single HST (CEM)
Comments The cumulative incidence rates of local recurrence between patients from ANBL0532 randomized or assigned to receive single CEM transplant and boost radiation and A3973 patients who were transplanted and received boost radiation were compared using Gray's test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5615
Comments [Not Specified]
Method Gray's test for competing risks
Comments [Not Specified]
Method of Estimation Estimation Parameter Gray's test statistic
Estimated Value 0.33709
Estimation Comments [Not Specified]
3.Primary Outcome
Title Response After Induction Therapy
Hide Description Per the International Response Criteria: measurable tumor defined as product of longest x widest perpendicular diameter. Elevated catecholamine levels, tumor cell invasion of bone marrow also considered measurable tumor. Complete Response (CR)-no evidence of primary tumor or metastases. Very Good Partial Response (VGPR)->90% reduction of primary tumor; no metastases; no new bone lesions, all pre-existing lesions improved. Partial Response (PR)-50-90% reduction of primary tumor; >50% reduction in measurable sites of metastases; 0-1 bone marrow samples with tumor; number of positive bone sites decreased by >50%. Mixed Response (MR)->50% reduction of any measurable lesion (primary or metastases) with <50% reduction in other sites; no new lesions; <25% increase in any existing lesion. No Response (NR)-no new lesions; <50% reduction but <25% increase in any existing legions. Progressive Disease (PD)-any new/increased measurable lesion by >25%; previous negative marrow positive.
Time Frame Study enrollment to the end of induction therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients evaluated for response at the end of induction therapy.
Arm/Group Title Single HST (CEM) Tandem HST (CEM), Randomly Assigned Not Assigned
Hide Arm/Group Description:
Induction therapy + single myeloablative consolidation
Induction therapy + tandem myeloablative consolidation
Patients that either failed during Induction therapy or refused randomization
Overall Number of Participants Analyzed 206 176 233
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Proportion participants that responded
0.54
(0.47 to 0.61)
0.48
(0.41 to 0.56)
0.35
(0.29 to 0.41)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Single HST (CEM), Tandem HST (CEM), Randomly Assigned, Not Assigned
Comments Chi-square test of proportions in all patients to compare the proportion of responders (complete response [CR]+ very good partial response [VGPR]) at the end of induction therapy in this study to an analogous cohort of responders in A3973.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0034
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Chi-squared test statistic
Estimated Value 8.5751
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Duration of Greater Than or Equal to Grade 3 Neutropenia
Hide Description A logistic regression model will be used to test the ability of the number of days of neutropenia to predict the presence of a polymorphism.
Time Frame 21 days
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Duration of Greater Than or Equal to Grade 3 Thrombocytopenia
Hide Description A logistic regression model will be used to test the ability of the number of days of thrombocytopenia to predict the presence of a polymorphism.
Time Frame 21 days
Outcome Measure Data Not Reported
6.Secondary Outcome
Title EFS Pts Non-randomly Assigned to Single CEM (12-18 Mths, Stg. 4, MYCN Nonamplified Tumor/Unfavorable or Indeterminant Histopathology/Diploid DNA Content & Pts>547 Days, Stg.3, MYCN Nonamplified Tumor AND Unfavorable or Indeterminant Histopathology).
Hide Description Kaplan-Meier curves of EFS will be plotted, and the proportion of responders to induction therapy will be tabulated.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients non-randomly assigned to single CEM
Arm/Group Title Single HST (CEM)
Hide Arm/Group Description:
Induction therapy + single myeloablative consolidation
Overall Number of Participants Analyzed 27
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percent probability
73.1
(55.1 to 91.2)
7.Secondary Outcome
Title Enumeration of Peripheral Blood Cluster of Differentiation (CD)3, CD4, and CD8 Cells
Time Frame Up to 6 months after completion of assigned myeloablation therapy
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients that had CD3, CD4 and CD8T-cell count evaluated at the end of reporting period 3.
Arm/Group Title Single HST (CEM) Tandem HST (CEM), Randomly Assigned
Hide Arm/Group Description:
Induction therapy + single myeloablative consolidation
Induction therapy + tandem myeloablative consolidation
Overall Number of Participants Analyzed 43 43
Median (Full Range)
Unit of Measure: cells/mm^3
CD3 Number Analyzed 43 participants 42 participants
200
(23 to 1549)
255.5
(13 to 2987)
CD4 Number Analyzed 42 participants 43 participants
73
(8 to 626)
81
(4 to 1186)
CD8 Number Analyzed 41 participants 43 participants
104
(8 to 1170)
151
(4 to 2529)
8.Secondary Outcome
Title Intraspinal Extension
Hide Description Proportion of patients with primary tumors with intraspinal extension.
Time Frame Up to 5 years
Outcome Measure Data Not Reported
9.Secondary Outcome
Title OS in Patients 12-18 Months, Stage 4, MYCN Nonamplified Tumor/Unfavorable Histopathology/Diploid DNA Content/Indeterminant Histology/Ploidy and Patients > 547 Days, Stage 3, MYCN Nonamplified Tumor AND Unfavorable Histopathology/Indeterminant Histology
Hide Description Kaplan-Meier curves of OS will be plotted, and the proportion of responders to induction therapy will be tabulated.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single HST (CEM)
Hide Arm/Group Description:
Induction therapy + single myeloablative consolidation
Overall Number of Participants Analyzed 27
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percent probability
81.0
(65.1 to 96.9)
10.Secondary Outcome
Title Peak Serum Concentration of Isotretinoin in Patients Enrolled on Either A3973, ANBL0032, ANBL0931, ANBL0532 and Future High Risk Studies
Hide Description Median peak serum concentration level of isotretinoin for patients enrolled on ANBL0532
Time Frame Day 1 of each course
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients evaluated for peak serum concentration level of isotretinoin.
Arm/Group Title Single HST (CEM) Tandem HST (CEM), Randomly Assigned Not Assigned
Hide Arm/Group Description:
Induction therapy + single myeloablative consolidation
Induction therapy + tandem myeloablative consolidation
Patients that either failed during Induction therapy or refused randomization
Overall Number of Participants Analyzed 91 76 49
Median (Full Range)
Unit of Measure: Micromolar
1.00
(0 to 9.22)
1.36
(0 to 12.93)
1.26
(0 to 11.78)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Single HST (CEM), Tandem HST (CEM), Randomly Assigned, Not Assigned
Comments The relationship between the peak serum isotretinoin concentration level with event-free survival was explored with a Cox proportional hazards model. Eligible patients treated with isotretinoin on A3973, ANBL0032, ANBL0532, or ANBL0931 with peak serum concentration level data were included in the analysis.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6853
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.015
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Pharmacogenetic Variants in Patients Enrolled on Either A3973, ANBL0032, ANBL0931, ANBL0532 and Future High Risk Studies
Hide Description To determine if pharmacogenomic variations are predictive of EFS, a logrank test comparison of patients with vs without a given polymorphism will be made. A Fisher’s exact test will test for association of the presence of a polymorphism with the occurrence of systemic toxicity (CTC grade 3 or 4 skin, hypercalcemia, or hepatic toxicity). These tests will be performed for UGT1A1, UGT2B7, CYP2C8 and CYP3A7 alleles.
Time Frame Baseline
Outcome Measure Data Not Reported
12.Secondary Outcome
Title Presence and Function of T Cells Capable of Recognizing Neuroblastoma
Hide Description [Not Specified]
Time Frame Up to 6 months (end of therapy)
Hide Outcome Measure Data
Hide Analysis Population Description
The data was not collected to assess this study aim.
Arm/Group Title Single HST (CEM) Tandem HST (CEM), Randomly Assigned Not Assigned
Hide Arm/Group Description:
Induction therapy + single myeloablative consolidation
Induction therapy + tandem myeloablative consolidation
Patients that either failed during Induction therapy or refused randomization
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
13.Secondary Outcome
Title Proportion of Patients With Neuroblastoma Detected in Bone Marrow and Peripheral Blood Using RT-PCR Technique
Hide Description Will be calculated overall and by treatment arm.
Time Frame Baseline
Outcome Measure Data Not Reported
14.Secondary Outcome
Title Response Rate
Hide Description A chi-square test of association will be used to compare the proportion of responders with versus without a polymorphism.
Time Frame 42 days
Outcome Measure Data Not Reported
15.Secondary Outcome
Title Surgical Response
Hide Description Proportion of patients who achieved a surgical complete resection
Time Frame Up to 3 years
Outcome Measure Data Not Reported
16.Secondary Outcome
Title Topotecan Systemic Clearance
Hide Description Median topotecan systemic clearance for courses 1 and 2.
Time Frame Day 1 of courses 1-2
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients evaluated for topotecan systemic clearance.
Arm/Group Title Single HST (CEM) Tandem HST (CEM), Randomly Assigned Not Assigned
Hide Arm/Group Description:
Induction therapy + single myeloablative consolidation
Induction therapy + tandem myeloablative consolidation
Patients that either failed during Induction therapy or refused randomization
Overall Number of Participants Analyzed 82 76 103
Median (Full Range)
Unit of Measure: L/h/m2
28.1
(14.9 to 49.4)
28.1
(11.6 to 42.7)
28.5
(16.3 to 54.7)
17.Secondary Outcome
Title Type of Surgical or Radiotherapy Complication
Hide Description The proportion of patients who experienced surgical or radiotherapy complications will be calculated. The complications are: bowel obstruction, chylous leaf, renal injury/atrophy/loss and diarrhea.
Time Frame Up to 3 years
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description We've excluded the ineligibles from this table.
 
Arm/Group Title Single HST (CEM) Tandem HST (CEM), Randomly Assigned Not Assigned
Hide Arm/Group Description Induction therapy + single myeloablative consolidation Induction therapy + tandem myeloablative consolidation Patients that either failed during Induction therapy or refused randomization
All-Cause Mortality
Single HST (CEM) Tandem HST (CEM), Randomly Assigned Not Assigned
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Single HST (CEM) Tandem HST (CEM), Randomly Assigned Not Assigned
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   16/206 (7.77%)      15/176 (8.52%)      12/269 (4.46%)    
Blood and lymphatic system disorders       
13200-Anemia  1/206 (0.49%)  1 0/176 (0.00%)  0 2/269 (0.74%)  2
17200-Blood and lymphatic system disorders - Other specify  0/206 (0.00%)  0 3/176 (1.70%)  3 0/269 (0.00%)  0
25800-Disseminated intravascular coagulation  2/206 (0.97%)  2 0/176 (0.00%)  0 1/269 (0.37%)  1
33300-Febrile neutropenia  1/206 (0.49%)  1 1/176 (0.57%)  1 0/269 (0.00%)  0
39600-Hemolysis  1/206 (0.49%)  1 0/176 (0.00%)  0 0/269 (0.00%)  0
39700-Hemolytic uremic syndrome  0/206 (0.00%)  0 0/176 (0.00%)  0 1/269 (0.37%)  1
Cardiac disorders       
20000-Cardiac arrest  3/206 (1.46%)  3 0/176 (0.00%)  0 1/269 (0.37%)  1
51700-Left ventricular systolic dysfunction  0/206 (0.00%)  0 1/176 (0.57%)  1 0/269 (0.00%)  0
63100-Pericardial effusion  1/206 (0.49%)  1 2/176 (1.14%)  2 2/269 (0.74%)  2
72700-Right ventricular dysfunction  0/206 (0.00%)  0 1/176 (0.57%)  1 0/269 (0.00%)  0
Eye disorders       
31900-Eye disorders - Other specify  0/206 (0.00%)  0 1/176 (0.57%)  1 0/269 (0.00%)  0
Gastrointestinal disorders       
14900-Ascites  2/206 (0.97%)  2 2/176 (1.14%)  2 0/269 (0.00%)  0
35900-Gastric hemorrhage  1/206 (0.49%)  1 0/176 (0.00%)  0 0/269 (0.00%)  0
36700-Gastrointestinal disorders - Other specify  1/206 (0.49%)  1 0/176 (0.00%)  0 0/269 (0.00%)  0
36900-Gastrointestinal pain  1/206 (0.49%)  1 0/176 (0.00%)  0 0/269 (0.00%)  0
53000-Lower gastrointestinal hemorrhage  1/206 (0.49%)  1 0/176 (0.00%)  0 1/269 (0.37%)  1
55600-Mucositis oral  2/206 (0.97%)  2 1/176 (0.57%)  1 0/269 (0.00%)  0
70100-Rectal hemorrhage  1/206 (0.49%)  1 0/176 (0.00%)  0 0/269 (0.00%)  0
75700-Small intestinal obstruction  1/206 (0.49%)  1 0/176 (0.00%)  0 0/269 (0.00%)  0
81900-Typhlitis  1/206 (0.49%)  1 0/176 (0.00%)  0 0/269 (0.00%)  0
82200-Upper gastrointestinal hemorrhage  1/206 (0.49%)  1 0/176 (0.00%)  0 0/269 (0.00%)  0
General disorders       
24600-Death NOS  0/206 (0.00%)  0 0/176 (0.00%)  0 2/269 (0.74%)  2
37200-General disorders and administration site conditions - Other specify  0/206 (0.00%)  0 1/176 (0.57%)  1 0/269 (0.00%)  0
55700-Multi-organ failure  4/206 (1.94%)  4 0/176 (0.00%)  0 2/269 (0.74%)  2
Hepatobiliary disorders       
40000-Hepatic failure  1/206 (0.49%)  1 1/176 (0.57%)  1 0/269 (0.00%)  0
40600-Hepatobiliary disorders - Other specify  1/206 (0.49%)  1 0/176 (0.00%)  0 0/269 (0.00%)  0
66500-Portal hypertension  1/206 (0.49%)  1 0/176 (0.00%)  0 0/269 (0.00%)  0
66600-Portal vein thrombosis  0/206 (0.00%)  0 0/176 (0.00%)  0 1/269 (0.37%)  1
Infections and infestations       
20500-Catheter related infection  0/206 (0.00%)  0 0/176 (0.00%)  0 1/269 (0.37%)  1
44800-Infections and infestations - Other specify  4/206 (1.94%)  4 0/176 (0.00%)  0 2/269 (0.74%)  2
73700-Sepsis  1/206 (0.49%)  1 1/176 (0.57%)  1 0/269 (0.00%)  0
Injury, poisoning and procedural complications       
13800-Aortic injury  0/206 (0.00%)  0 0/176 (0.00%)  0 1/269 (0.37%)  1
45400-Injury to inferior vena cava  0/206 (0.00%)  0 0/176 (0.00%)  0 1/269 (0.37%)  1
47700-Intraoperative renal injury  0/206 (0.00%)  0 0/176 (0.00%)  0 1/269 (0.37%)  1
Investigations       
10900-Activated partial thromboplastin time prolonged  0/206 (0.00%)  0 1/176 (0.57%)  1 1/269 (0.37%)  1
11600-Alanine aminotransferase increased  3/206 (1.46%)  3 1/176 (0.57%)  1 2/269 (0.74%)  2
15000-Aspartate aminotransferase increased  3/206 (1.46%)  3 1/176 (0.57%)  1 3/269 (1.12%)  3
17400-Blood bilirubin increased  4/206 (1.94%)  4 1/176 (0.57%)  1 2/269 (0.74%)  2
24100-Creatinine increased  3/206 (1.46%)  3 0/176 (0.00%)  0 2/269 (0.74%)  2
37500-GGT increased  0/206 (0.00%)  0 0/176 (0.00%)  0 1/269 (0.37%)  1
45800-INR increased  0/206 (0.00%)  0 1/176 (0.57%)  1 0/269 (0.00%)  0
58300-Neutrophil count decreased  0/206 (0.00%)  0 0/176 (0.00%)  0 1/269 (0.37%)  1
65800-Platelet count decreased  1/206 (0.49%)  1 0/176 (0.00%)  0 1/269 (0.37%)  1
88200-Weight gain  0/206 (0.00%)  0 1/176 (0.57%)  1 0/269 (0.00%)  0
88500-White blood cell decreased  1/206 (0.49%)  1 0/176 (0.00%)  0 1/269 (0.37%)  1
Metabolism and nutrition disorders       
41300-Hypercalcemia  0/206 (0.00%)  0 1/176 (0.57%)  1 0/269 (0.00%)  0
41800-Hypernatremia  2/206 (0.97%)  2 0/176 (0.00%)  0 0/269 (0.00%)  0
42600-Hypoalbuminemia  1/206 (0.49%)  1 0/176 (0.00%)  0 1/269 (0.37%)  1
42700-Hypocalcemia  0/206 (0.00%)  0 1/176 (0.57%)  1 0/269 (0.00%)  0
43100-Hypokalemia  0/206 (0.00%)  0 0/176 (0.00%)  0 2/269 (0.74%)  2
43300-Hyponatremia  1/206 (0.49%)  1 0/176 (0.00%)  0 0/269 (0.00%)  0
43500-Hypophosphatemia  1/206 (0.49%)  1 0/176 (0.00%)  0 1/269 (0.37%)  1
54900-Metabolism and nutrition disorders - Other specify  1/206 (0.49%)  1 1/176 (0.57%)  3 0/269 (0.00%)  0
81700-Tumor lysis syndrome  0/206 (0.00%)  0 0/176 (0.00%)  0 1/269 (0.37%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
58000-Neoplasms benign malignant and unspecified (incl cysts and polyps) - Other specify  0/206 (0.00%)  0 1/176 (0.57%)  1 0/269 (0.00%)  0
81200-Treatment related secondary malignancy  1/206 (0.49%)  1 1/176 (0.57%)  1 0/269 (0.00%)  0
Nervous system disorders       
25300-Depressed level of consciousness  1/206 (0.49%)  1 0/176 (0.00%)  0 0/269 (0.00%)  0
29000-Encephalopathy  0/206 (0.00%)  0 1/176 (0.57%)  1 1/269 (0.37%)  1
56600-Myelitis  0/206 (0.00%)  0 1/176 (0.57%)  1 0/269 (0.00%)  0
58100-Nervous system disorders - Other specify  0/206 (0.00%)  0 1/176 (0.57%)  1 1/269 (0.37%)  1
Renal and urinary disorders       
11100-Acute kidney injury  3/206 (1.46%)  3 0/176 (0.00%)  0 3/269 (1.12%)  3
71000-Renal and urinary disorders - Other specify  0/206 (0.00%)  0 1/176 (0.57%)  1 0/269 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
19200-Bronchopulmonary hemorrhage  1/206 (0.49%)  1 0/176 (0.00%)  0 0/269 (0.00%)  0
27800-Dyspnea  0/206 (0.00%)  0 1/176 (0.57%)  1 0/269 (0.00%)  0
29700-Epistaxis  1/206 (0.49%)  1 0/176 (0.00%)  0 0/269 (0.00%)  0
43900-Hypoxia  2/206 (0.97%)  2 4/176 (2.27%)  4 2/269 (0.74%)  2
65900-Pleural effusion  0/206 (0.00%)  0 2/176 (1.14%)  2 2/269 (0.74%)  2
66300-Pneumonitis  0/206 (0.00%)  0 1/176 (0.57%)  1 0/269 (0.00%)  0
69000-Pulmonary hypertension  0/206 (0.00%)  0 1/176 (0.57%)  1 0/269 (0.00%)  0
71500-Respiratory failure  2/206 (0.97%)  2 1/176 (0.57%)  1 2/269 (0.74%)  2
71600-Respiratory thoracic and mediastinal disorders - Other specify  2/206 (0.97%)  2 0/176 (0.00%)  0 1/269 (0.37%)  1
Skin and subcutaneous tissue disorders       
75300-Skin ulceration  1/206 (0.49%)  1 0/176 (0.00%)  0 0/269 (0.00%)  0
Surgical and medical procedures       
79000-Surgical and medical procedures - Other specify  0/206 (0.00%)  0 0/176 (0.00%)  0 1/269 (0.37%)  1
Vascular disorders       
42100-Hypertension  1/206 (0.49%)  1 1/176 (0.57%)  1 0/269 (0.00%)  0
43600-Hypotension  1/206 (0.49%)  1 1/176 (0.57%)  1 0/269 (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%
Single HST (CEM) Tandem HST (CEM), Randomly Assigned Not Assigned
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   196/206 (95.15%)      163/176 (92.61%)      230/269 (85.50%)    
Blood and lymphatic system disorders       
13200-Anemia  23/206 (11.17%)  35 22/176 (12.50%)  37 33/269 (12.27%)  42
17200-Blood and lymphatic system disorders - Other specify  0/206 (0.00%)  0 1/176 (0.57%)  1 0/269 (0.00%)  0
25800-Disseminated intravascular coagulation  2/206 (0.97%)  2 0/176 (0.00%)  0 1/269 (0.37%)  1
33300-Febrile neutropenia  32/206 (15.53%)  46 32/176 (18.18%)  41 46/269 (17.10%)  53
Cardiac disorders       
20000-Cardiac arrest  1/206 (0.49%)  1 0/176 (0.00%)  0 1/269 (0.37%)  1
20100-Cardiac disorders - Other specify  0/206 (0.00%)  0 1/176 (0.57%)  1 0/269 (0.00%)  0
39000-Heart failure  1/206 (0.49%)  1 0/176 (0.00%)  0 0/269 (0.00%)  0
63100-Pericardial effusion  0/206 (0.00%)  0 1/176 (0.57%)  1 0/269 (0.00%)  0
72700-Right ventricular dysfunction  1/206 (0.49%)  1 0/176 (0.00%)  0 0/269 (0.00%)  0
Ear and labyrinth disorders       
27900-Ear and labyrinth disorders - Other specify  1/206 (0.49%)  1 0/176 (0.00%)  0 0/269 (0.00%)  0
38900-Hearing impaired  6/206 (2.91%)  6 4/176 (2.27%)  4 3/269 (1.12%)  3
Endocrine disorders       
11200-Adrenal insufficiency  0/206 (0.00%)  0 0/176 (0.00%)  0 1/269 (0.37%)  1
Eye disorders       
31900-Eye disorders - Other specify  0/206 (0.00%)  0 0/176 (0.00%)  0 1/269 (0.37%)  1
Gastrointestinal disorders       
10100-Abdominal distension  1/206 (0.49%)  1 0/176 (0.00%)  0 0/269 (0.00%)  0
10300-Abdominal pain  5/206 (2.43%)  5 5/176 (2.84%)  8 6/269 (2.23%)  6
14900-Ascites  2/206 (0.97%)  2 3/176 (1.70%)  3 0/269 (0.00%)  0
22100-Colitis  1/206 (0.49%)  1 2/176 (1.14%)  2 1/269 (0.37%)  1
25700-Diarrhea  20/206 (9.71%)  21 7/176 (3.98%)  7 10/269 (3.72%)  10
26600-Duodenal obstruction  0/206 (0.00%)  0 1/176 (0.57%)  1 0/269 (0.00%)  0
29400-Enterocolitis  1/206 (0.49%)  1 0/176 (0.00%)  0 1/269 (0.37%)  1
31200-Esophagitis  1/206 (0.49%)  1 1/176 (0.57%)  1 2/269 (0.74%)  2
36400-Gastritis  1/206 (0.49%)  1 0/176 (0.00%)  0 1/269 (0.37%)  1
36700-Gastrointestinal disorders - Other specify  2/206 (0.97%)  2 0/176 (0.00%)  0 0/269 (0.00%)  0
44200-Ileal obstruction  0/206 (0.00%)  0 1/176 (0.57%)  1 0/269 (0.00%)  0
44600-Ileus  2/206 (0.97%)  2 0/176 (0.00%)  0 8/269 (2.97%)  8
46300-Intra-abdominal hemorrhage  1/206 (0.49%)  1 0/176 (0.00%)  0 1/269 (0.37%)  1
53000-Lower gastrointestinal hemorrhage  1/206 (0.49%)  1 0/176 (0.00%)  0 0/269 (0.00%)  0
55600-Mucositis oral  20/206 (9.71%)  21 16/176 (9.09%)  16 6/269 (2.23%)  6
57600-Nausea  4/206 (1.94%)  5 6/176 (3.41%)  6 2/269 (0.74%)  2
58900-Obstruction gastric  1/206 (0.49%)  1 0/176 (0.00%)  0 0/269 (0.00%)  0
59700-Oral pain  2/206 (0.97%)  2 5/176 (2.84%)  5 0/269 (0.00%)  0
75600-Small intestinal mucositis  0/206 (0.00%)  0 1/176 (0.57%)  1 0/269 (0.00%)  0
75700-Small intestinal obstruction  1/206 (0.49%)  1 3/176 (1.70%)  3 2/269 (0.74%)  2
81900-Typhlitis  0/206 (0.00%)  0 2/176 (1.14%)  2 1/269 (0.37%)  1
87900-Vomiting  7/206 (3.40%)  8 4/176 (2.27%)  4 8/269 (2.97%)  10
General disorders       
28200-Edema face  1/206 (0.49%)  1 0/176 (0.00%)  0 0/269 (0.00%)  0
33200-Fatigue  1/206 (0.49%)  1 0/176 (0.00%)  0 1/269 (0.37%)  1
33900-Fever  4/206 (1.94%)  4 1/176 (0.57%)  1 1/269 (0.37%)  1
37200-General disorders and administration site conditions - Other specify  1/206 (0.49%)  1 0/176 (0.00%)  0 0/269 (0.00%)  0
48700-Irritability  1/206 (0.49%)  1 0/176 (0.00%)  0 0/269 (0.00%)  0
60600-Pain  1/206 (0.49%)  1 0/176 (0.00%)  0 4/269 (1.49%)  4
Hepatobiliary disorders       
35500-Gallbladder pain  0/206 (0.00%)  0 1/176 (0.57%)  1 0/269 (0.00%)  0
40600-Hepatobiliary disorders - Other specify  2/206 (0.97%)  2 2/176 (1.14%)  2 1/269 (0.37%)  1
66500-Portal hypertension  0/206 (0.00%)  0 1/176 (0.57%)  1 0/269 (0.00%)  0
Immune system disorders       
12000-Allergic reaction  0/206 (0.00%)  0 1/176 (0.57%)  2 0/269 (0.00%)  0
13100-Anaphylaxis  0/206 (0.00%)  0 2/176 (1.14%)  2 1/269 (0.37%)  1
44700-Immune system disorders - Other specify  0/206 (0.00%)  0 1/176 (0.57%)  1 1/269 (0.37%)  1
Infections and infestations       
13400-Anorectal infection  1/206 (0.49%)  1 1/176 (0.57%)  1 0/269 (0.00%)  0
16800-Bladder infection  0/206 (0.00%)  0 0/176 (0.00%)  0 1/269 (0.37%)  1
20500-Catheter related infection  6/206 (2.91%)  7 5/176 (2.84%)  5 4/269 (1.49%)  4
25600-Device related infection  0/206 (0.00%)  0 2/176 (1.14%)  2 0/269 (0.00%)  0
29500-Enterocolitis infectious  4/206 (1.94%)  4 2/176 (1.14%)  2 4/269 (1.49%)  4
38300-Gum infection  0/206 (0.00%)  0 0/176 (0.00%)  0 1/269 (0.37%)  1
44800-Infections and infestations - Other specify  36/206 (17.48%)  48 32/176 (18.18%)  45 39/269 (14.50%)  68
53100-Lung infection  4/206 (1.94%)  4 1/176 (0.57%)  1 2/269 (0.74%)  2
60100-Otitis media  1/206 (0.49%)  1 0/176 (0.00%)  0 0/269 (0.00%)  0
62500-Pelvic infection  0/206 (0.00%)  0 1/176 (0.57%)  1 0/269 (0.00%)  0
66100-Pleural infection  1/206 (0.49%)  1 0/176 (0.00%)  0 0/269 (0.00%)  0
73700-Sepsis  16/206 (7.77%)  16 11/176 (6.25%)  13 2/269 (0.74%)  3
75200-Skin infection  1/206 (0.49%)  1 2/176 (1.14%)  2 1/269 (0.37%)  1
76000-Small intestine infection  1/206 (0.49%)  1 0/176 (0.00%)  0 1/269 (0.37%)  2
82300-Upper respiratory infection  2/206 (0.97%)  2 1/176 (0.57%)  1 1/269 (0.37%)  1
83100-Urinary tract infection  0/206 (0.00%)  0 2/176 (1.14%)  2 2/269 (0.74%)  2
88900-Wound infection  0/206 (0.00%)  0 0/176 (0.00%)  0 2/269 (0.74%)  2
Injury, poisoning and procedural complications       
14500-Arterial injury  0/206 (0.00%)  0 1/176 (0.57%)  1 0/269 (0.00%)  0
34900-Fracture  1/206 (0.49%)  1 0/176 (0.00%)  0 0/269 (0.00%)  0
46500-Intraoperative arterial injury  0/206 (0.00%)  0 0/176 (0.00%)  0 3/269 (1.12%)  3
66800-Postoperative hemorrhage  1/206 (0.49%)  1 1/176 (0.57%)  1 3/269 (1.12%)  3
66900-Postoperative thoracic procedure complication  0/206 (0.00%)  0 0/176 (0.00%)  0 1/269 (0.37%)  1
80700-Tracheal obstruction  0/206 (0.00%)  0 0/176 (0.00%)  0 1/269 (0.37%)  1
86400-Vascular access complication  0/206 (0.00%)  0 0/176 (0.00%)  0 1/269 (0.37%)  1
Investigations       
10900-Activated partial thromboplastin time prolonged  0/206 (0.00%)  0 2/176 (1.14%)  2 1/269 (0.37%)  1
11600-Alanine aminotransferase increased  18/206 (8.74%)  18 12/176 (6.82%)  14 8/269 (2.97%)  9
11800-Alkaline phosphatase increased  1/206 (0.49%)  1 1/176 (0.57%)  1 0/269 (0.00%)  0
15000-Aspartate aminotransferase increased  19/206 (9.22%)  19 11/176 (6.25%)  11 7/269 (2.60%)  7
17400-Blood bilirubin increased  1/206 (0.49%)  1 2/176 (1.14%)  2 1/269 (0.37%)  2
24100-Creatinine increased  3/206 (1.46%)  3 2/176 (1.14%)  2 0/269 (0.00%)  0
34000-Fibrinogen decreased  1/206 (0.49%)  1 1/176 (0.57%)  1 3/269 (1.12%)  3
37500-GGT increased  3/206 (1.46%)  3 5/176 (2.84%)  5 1/269 (0.37%)  2
45800-INR increased  0/206 (0.00%)  0 1/176 (0.57%)  1 0/269 (0.00%)  0
52600-Lipase increased  0/206 (0.00%)  0 1/176 (0.57%)  1 1/269 (0.37%)  1
53700-Lymphocyte count decreased  13/206 (6.31%)  17 11/176 (6.25%)  16 12/269 (4.46%)  16
58300-Neutrophil count decreased  185/206 (89.81%)  254 148/176 (84.09%)  192 217/269 (80.67%)  287
65800-Platelet count decreased  146/206 (70.87%)  237 124/176 (70.45%)  177 175/269 (65.06%)  269
73900-Serum amylase increased  0/206 (0.00%)  0 2/176 (1.14%)  2 1/269 (0.37%)  1
83600-Urine output decreased  1/206 (0.49%)  1 0/176 (0.00%)  0 0/269 (0.00%)  0
88300-Weight loss  2/206 (0.97%)  2 0/176 (0.00%)  0 0/269 (0.00%)  0
88500-White blood cell decreased  32/206 (15.53%)  48 30/176 (17.05%)  42 36/269 (13.38%)  52
Metabolism and nutrition disorders       
10700-Acidosis  2/206 (0.97%)  2 1/176 (0.57%)  1 1/269 (0.37%)  1
11900-Alkalosis  1/206 (0.49%)  1 0/176 (0.00%)  0 0/269 (0.00%)  0
13500-Anorexia  16/206 (7.77%)  21 13/176 (7.39%)  17 11/269 (4.09%)  16
24700-Dehydration  4/206 (1.94%)  4 2/176 (1.14%)  2 7/269 (2.60%)  7
41300-Hypercalcemia  4/206 (1.94%)  4 0/176 (0.00%)  0 2/269 (0.74%)  2
41400-Hyperglycemia  8/206 (3.88%)  8 13/176 (7.39%)  15 11/269 (4.09%)  12
41600-Hyperkalemia  7/206 (3.40%)  7 6/176 (3.41%)  6 2/269 (0.74%)  3
41700-Hypermagnesemia  0/206 (0.00%)  0 0/176 (0.00%)  0 1/269 (0.37%)  1
42500-Hyperuricemia  0/206 (0.00%)  0 1/176 (0.57%)  1 0/269 (0.00%)  0
42600-Hypoalbuminemia  2/206 (0.97%)  2 2/176 (1.14%)  2 2/269 (0.74%)  3
42700-Hypocalcemia  10/206 (4.85%)  10 12/176 (6.82%)  13 5/269 (1.86%)  7
42900-Hypoglycemia  1/206 (0.49%)  1 0/176 (0.00%)  0 0/269 (0.00%)  0
43100-Hypokalemia  38/206 (18.45%)  48 36/176 (20.45%)  43 22/269 (8.18%)  26
43200-Hypomagnesemia  3/206 (1.46%)  3 1/176 (0.57%)  1 0/269 (0.00%)  0
43300-Hyponatremia  6/206 (2.91%)  7 11/176 (6.25%)  13 8/269 (2.97%)  8
43500-Hypophosphatemia  3/206 (1.46%)  3 2/176 (1.14%)  2 4/269 (1.49%)  4
48500-Iron overload  1/206 (0.49%)  1 0/176 (0.00%)  0 0/269 (0.00%)  0
Musculoskeletal and connective tissue disorders       
14700-Arthralgia  0/206 (0.00%)  0 0/176 (0.00%)  0 1/269 (0.37%)  1
16200-Back pain  0/206 (0.00%)  0 0/176 (0.00%)  0 1/269 (0.37%)  1
37300-Generalized muscle weakness  1/206 (0.49%)  1 1/176 (0.57%)  1 0/269 (0.00%)  0
55900-Muscle weakness lower limb  0/206 (0.00%)  0 0/176 (0.00%)  0 1/269 (0.37%)  1
60700-Pain in extremity  1/206 (0.49%)  1 0/176 (0.00%)  0 0/269 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
58000-Neoplasms benign malignant and unspecified (incl cysts and polyps) - Other specify  1/206 (0.49%)  1 0/176 (0.00%)  0 0/269 (0.00%)  0
Nervous system disorders       
15300-Ataxia  0/206 (0.00%)  0 1/176 (0.57%)  1 0/269 (0.00%)  0
22000-Cognitive disturbance  0/206 (0.00%)  0 0/176 (0.00%)  0 1/269 (0.37%)  1
25300-Depressed level of consciousness  0/206 (0.00%)  0 0/176 (0.00%)  0 1/269 (0.37%)  1
31800-Extrapyramidal disorder  0/206 (0.00%)  0 1/176 (0.57%)  1 0/269 (0.00%)  0
38800-Headache  0/206 (0.00%)  0 1/176 (0.57%)  1 1/269 (0.37%)  1
58100-Nervous system disorders - Other specify  0/206 (0.00%)  0 0/176 (0.00%)  0 1/269 (0.37%)  1
63900-Peripheral motor neuropathy  0/206 (0.00%)  0 1/176 (0.57%)  1 0/269 (0.00%)  0
64100-Peripheral sensory neuropathy  1/206 (0.49%)  1 0/176 (0.00%)  0 0/269 (0.00%)  0
73600-Seizure  0/206 (0.00%)  0 0/176 (0.00%)  0 1/269 (0.37%)  1
Psychiatric disorders       
11400-Agitation  0/206 (0.00%)  0 0/176 (0.00%)  0 1/269 (0.37%)  1
23000-Confusion  0/206 (0.00%)  0 2/176 (1.14%)  2 0/269 (0.00%)  0
Renal and urinary disorders       
11100-Acute kidney injury  3/206 (1.46%)  3 1/176 (0.57%)  1 2/269 (0.74%)  2
39300-Hematuria  1/206 (0.49%)  1 0/176 (0.00%)  0 1/269 (0.37%)  1
Reproductive system and breast disorders       
62600-Pelvic pain  0/206 (0.00%)  0 1/176 (0.57%)  1 0/269 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
11300-Adult respiratory distress syndrome  3/206 (1.46%)  3 1/176 (0.57%)  1 0/269 (0.00%)  0
14100-Apnea  2/206 (0.97%)  2 0/176 (0.00%)  0 1/269 (0.37%)  1
15100-Aspiration  0/206 (0.00%)  0 0/176 (0.00%)  0 2/269 (0.74%)  2
15400-Atelectasis  1/206 (0.49%)  1 0/176 (0.00%)  0 1/269 (0.37%)  1
19200-Bronchopulmonary hemorrhage  0/206 (0.00%)  0 0/176 (0.00%)  0 1/269 (0.37%)  1
27800-Dyspnea  2/206 (0.97%)  2 0/176 (0.00%)  0 1/269 (0.37%)  1
29700-Epistaxis  2/206 (0.97%)  2 1/176 (0.57%)  1 1/269 (0.37%)  1
43900-Hypoxia  8/206 (3.88%)  11 3/176 (1.70%)  3 7/269 (2.60%)  7
64900-Pharyngeal mucositis  1/206 (0.49%)  1 0/176 (0.00%)  0 0/269 (0.00%)  0
65300-Pharyngolaryngeal pain  0/206 (0.00%)  0 1/176 (0.57%)  1 1/269 (0.37%)  1
65900-Pleural effusion  6/206 (2.91%)  6 5/176 (2.84%)  5 4/269 (1.49%)  4
66300-Pneumonitis  0/206 (0.00%)  0 2/176 (1.14%)  2 1/269 (0.37%)  1
68700-Pulmonary edema  0/206 (0.00%)  0 0/176 (0.00%)  0 1/269 (0.37%)  1
69000-Pulmonary hypertension  1/206 (0.49%)  1 0/176 (0.00%)  0 0/269 (0.00%)  0
71500-Respiratory failure  2/206 (0.97%)  2 1/176 (0.57%)  2 0/269 (0.00%)  0
71600-Respiratory thoracic and mediastinal disorders - Other specify  1/206 (0.49%)  1 0/176 (0.00%)  0 4/269 (1.49%)  4
78100-Stridor  0/206 (0.00%)  0 1/176 (0.57%)  1 0/269 (0.00%)  0
Skin and subcutaneous tissue disorders       
68400-Pruritus  0/206 (0.00%)  0 1/176 (0.57%)  1 0/269 (0.00%)  0
69700-Rash maculo-papular  1/206 (0.49%)  1 1/176 (0.57%)  1 0/269 (0.00%)  0
75300-Skin ulceration  0/206 (0.00%)  0 0/176 (0.00%)  0 1/269 (0.37%)  1
84100-Urticaria  1/206 (0.49%)  1 0/176 (0.00%)  0 0/269 (0.00%)  0
Vascular disorders       
42100-Hypertension  6/206 (2.91%)  6 1/176 (0.57%)  1 4/269 (1.49%)  5
43600-Hypotension  9/206 (4.37%)  9 3/176 (1.70%)  3 5/269 (1.86%)  5
53300-Lymph leakage  2/206 (0.97%)  2 0/176 (0.00%)  0 0/269 (0.00%)  0
79600-Thromboembolic event  2/206 (0.97%)  3 0/176 (0.00%)  0 0/269 (0.00%)  0
86500-Vascular disorders - Other specify  1/206 (0.49%)  1 0/176 (0.00%)  0 0/269 (0.00%)  0
87500-Visceral arterial ischemia  1/206 (0.49%)  1 0/176 (0.00%)  0 0/269 (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
Layout table for Results Point of Contact information
Name/Title: Results Reporting Coordinator
Organization: Children's Oncology Group
Phone: 626-447-0064
EMail: Resultsreportingcoordinator@childrensoncologygroup.org
Layout table for additonal information
Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00567567     History of Changes
Other Study ID Numbers: ANBL0532
NCI-2009-01065 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000576571
08-524
COG-ANBL0532
ANBL0532 ( Other Identifier: Childrens Oncology Group )
ANBL0532 ( Other Identifier: CTEP )
U10CA180886 ( U.S. NIH Grant/Contract )
U10CA098543 ( U.S. NIH Grant/Contract )
First Submitted: December 4, 2007
First Posted: December 5, 2007
Results First Submitted: January 20, 2017
Results First Posted: June 27, 2017
Last Update Posted: May 1, 2019