Trial Outcomes & Findings for Combination Chemotherapy With or Without Radiation Therapy in Treating Young Patients With Newly Diagnosed Stage III or Stage IV Wilms' Tumor (NCT NCT00379340)
NCT ID: NCT00379340
Last Updated: 2025-10-27
Results Overview
Probability of no relapse, secondary malignancy, or death after 4 year in the study.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
395 participants
Primary outcome timeframe
4 years
Results posted on
2025-10-27
Participant Flow
The 15 discrepant patients were ineligible to the study. They were excluded in the Participant Flow table because none of them were treated by the protocol and their group designations were unknown.
Participant milestones
| Measure |
Stage IV and Rapid Complete Response (RCR) of Lung Metastases
Stage IV and rapid complete response (RCR) of lung metastases continuously treated with DD4A after 6 weeks of DD4A.
|
Stage IV and Slow Incomplete Response (SIR) of Lung Metastases
Stage IV and slow incomplete response (SIR) of lung metastases treated with Regimen M after 6 weeks of DD4A.
|
Stage III/IV With LOH 1p and 16q Treated With Regimen M
Stage III/IV with LOH 1p and 16q treated with Regimen M.
|
Stage IV With Non-lung Disease Treated With Regimen M
Stage IV with non-lung disease treated with Regimen M.
|
Stage IV With Lung Metastases
Stage IV with lung metastases treated with DD4A for less than 6 weeks and/or response inevaluable at week 6.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
120
|
135
|
52
|
50
|
23
|
|
Overall Study
COMPLETED
|
107
|
132
|
50
|
37
|
9
|
|
Overall Study
NOT COMPLETED
|
13
|
3
|
2
|
13
|
14
|
Reasons for withdrawal
| Measure |
Stage IV and Rapid Complete Response (RCR) of Lung Metastases
Stage IV and rapid complete response (RCR) of lung metastases continuously treated with DD4A after 6 weeks of DD4A.
|
Stage IV and Slow Incomplete Response (SIR) of Lung Metastases
Stage IV and slow incomplete response (SIR) of lung metastases treated with Regimen M after 6 weeks of DD4A.
|
Stage III/IV With LOH 1p and 16q Treated With Regimen M
Stage III/IV with LOH 1p and 16q treated with Regimen M.
|
Stage IV With Non-lung Disease Treated With Regimen M
Stage IV with non-lung disease treated with Regimen M.
|
Stage IV With Lung Metastases
Stage IV with lung metastases treated with DD4A for less than 6 weeks and/or response inevaluable at week 6.
|
|---|---|---|---|---|---|
|
Overall Study
Death
|
0
|
0
|
0
|
2
|
0
|
|
Overall Study
Lack of Efficacy
|
6
|
1
|
0
|
4
|
3
|
|
Overall Study
Physician Decision
|
6
|
2
|
1
|
2
|
3
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Refusal of further protocol therapy
|
1
|
0
|
1
|
1
|
7
|
|
Overall Study
On more than 1 tumor therapeutic study
|
0
|
0
|
0
|
2
|
0
|
|
Overall Study
Delayed nephrectomy and anaplasia
|
0
|
0
|
0
|
1
|
1
|
Baseline Characteristics
Combination Chemotherapy With or Without Radiation Therapy in Treating Young Patients With Newly Diagnosed Stage III or Stage IV Wilms' Tumor
Baseline characteristics by cohort
| Measure |
Stage IV and Rapid Complete Response (RCR) of Lung Metastases
n=120 Participants
Stage IV and rapid complete response (RCR) of lung metastases continuously treated with DD4A after 6 weeks of DD4A.
|
Stage IV and Slow Incomplete Response (SIR) of Lung Metastases
n=135 Participants
Stage IV and slow incomplete response (SIR) of lung metastases treated with Regimen M after 6 weeks of DD4A.
|
Stage III/IV With LOH 1p and 16q Treated With Regimen M
n=52 Participants
Stage III/IV with LOH 1p and 16q treated with Regimen M.
|
Stage IV With Non-lung Disease Treated With Regimen M
n=50 Participants
Stage IV with non-lung disease treated with Regimen M.
|
Stage IV With Lung Metastases
n=23 Participants
Stage IV with lung metastases treated with DD4A for less than 6 weeks and/or response inevaluable at week 6.
|
Total
n=380 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
54.94 Months
STANDARD_DEVIATION 36.27 • n=5 Participants
|
55.07 Months
STANDARD_DEVIATION 27.16 • n=7 Participants
|
52.16 Months
STANDARD_DEVIATION 28.64 • n=5 Participants
|
69.58 Months
STANDARD_DEVIATION 39.24 • n=4 Participants
|
56.06 Months
STANDARD_DEVIATION 23.71 • n=21 Participants
|
56.60 Months
STANDARD_DEVIATION 32.29 • n=10 Participants
|
|
Sex: Female, Male
Female
|
65 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
205 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
175 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
51 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
104 Participants
n=5 Participants
|
108 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
308 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
21 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
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
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
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=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
21 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
58 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
80 Participants
n=5 Participants
|
94 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
269 Participants
n=10 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=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
16 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
45 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: 4 yearsProbability of no relapse, secondary malignancy, or death after 4 year in the study.
Outcome measures
| Measure |
Stage IV and Rapid Complete Response (RCR) of Lung Metastases
n=120 Participants
Stage IV and rapid complete response (RCR) of lung metastases continuously treated with DD4A after 6 weeks of DD4A.
|
Stage IV With Non-lung Disease Treated With Regimen M
Stage IV with non-lung disease treated with Regimen M
doxorubicin hydrochloride: Given IV
liposomal vincristine sulfate: Given IV
conventional surgery
dactinomycin: Given IV
cyclophosphamide: Given IV
etoposide: Given IV
|
|---|---|---|
|
Event Free Survival Probability
|
0.79 Probability
Interval 0.7 to 0.87
|
—
|
PRIMARY outcome
Timeframe: At 4 yearsPopulation: Analysis includes only eligible patients.
Probability of no relapse, secondary malignancy, or death after 4 year in the study.
Outcome measures
| Measure |
Stage IV and Rapid Complete Response (RCR) of Lung Metastases
n=135 Participants
Stage IV and rapid complete response (RCR) of lung metastases continuously treated with DD4A after 6 weeks of DD4A.
|
Stage IV With Non-lung Disease Treated With Regimen M
Stage IV with non-lung disease treated with Regimen M
doxorubicin hydrochloride: Given IV
liposomal vincristine sulfate: Given IV
conventional surgery
dactinomycin: Given IV
cyclophosphamide: Given IV
etoposide: Given IV
|
|---|---|---|
|
Event Free Survival (EFS) Probability
|
0.89 Probability of EFS at 4 years
Interval 0.82 to 0.95
|
—
|
PRIMARY outcome
Timeframe: At 4 yearsPopulation: All eligible patients were included in this analysis.
Probability of no relapse, secondary malignancy, or death after 4 year in the study
Outcome measures
| Measure |
Stage IV and Rapid Complete Response (RCR) of Lung Metastases
n=52 Participants
Stage IV and rapid complete response (RCR) of lung metastases continuously treated with DD4A after 6 weeks of DD4A.
|
Stage IV With Non-lung Disease Treated With Regimen M
n=50 Participants
Stage IV with non-lung disease treated with Regimen M
doxorubicin hydrochloride: Given IV
liposomal vincristine sulfate: Given IV
conventional surgery
dactinomycin: Given IV
cyclophosphamide: Given IV
etoposide: Given IV
|
|---|---|---|
|
Event Free Survival Probability
|
0.90 Probability of EFS at 4 years
Interval 0.8 to 1.0
|
0.73 Probability of EFS at 4 years
Interval 0.59 to 0.88
|
SECONDARY outcome
Timeframe: At 4 yearsPopulation: Analysis population is eligible stage (stg) IV patients (pts) with lung mets only. On Participant Flow table, these pts include 120 RCR, 135 SIR, 21 stg IV with LOH (of 52 when including stg III), and 23 stg IV with lung mets (off therapy before week 6). A total of 299 stg IV pts, exceeding the total number of participant (297) analyzed for OM 4.
Probability of no relapse, secondary malignancy, or death after 4 year in the study.
Outcome measures
| Measure |
Stage IV and Rapid Complete Response (RCR) of Lung Metastases
n=147 Participants
Stage IV and rapid complete response (RCR) of lung metastases continuously treated with DD4A after 6 weeks of DD4A.
|
Stage IV With Non-lung Disease Treated With Regimen M
n=150 Participants
Stage IV with non-lung disease treated with Regimen M
doxorubicin hydrochloride: Given IV
liposomal vincristine sulfate: Given IV
conventional surgery
dactinomycin: Given IV
cyclophosphamide: Given IV
etoposide: Given IV
|
|---|---|---|
|
Event Free Survival Associated With the Burden of Pulmonary Metastatic Disease
|
0.88 Probability
Interval 0.82 to 0.95
|
0.82 Probability
Interval 0.75 to 0.9
|
Adverse Events
Stage IV and Rapid Complete Response (RCR) of Lung Metastases
Serious events: 3 serious events
Other events: 11 other events
Deaths: 0 deaths
Stage IV and Slow Incomplete Response (SIR) of Lung Metastases
Serious events: 10 serious events
Other events: 90 other events
Deaths: 0 deaths
Stage III/IV With LOH 1p and 16q Treated With Regimen M
Serious events: 3 serious events
Other events: 35 other events
Deaths: 0 deaths
Stage IV With Non-lung Disease Treated With Regimen M
Serious events: 11 serious events
Other events: 37 other events
Deaths: 0 deaths
Stage IV With Lung Metastases
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Stage IV and Rapid Complete Response (RCR) of Lung Metastases
n=120 participants at risk
Stage IV and rapid complete response (RCR) of lung metastases continuously treated with DD4A after 6 weeks of DD4A.
|
Stage IV and Slow Incomplete Response (SIR) of Lung Metastases
n=135 participants at risk
Stage IV and slow incomplete response (SIR) of lung metastases treated with Regimen M after 6 weeks of DD4A.
|
Stage III/IV With LOH 1p and 16q Treated With Regimen M
n=52 participants at risk
Stage III/IV with LOH 1p and 16q treated with Regimen M.
|
Stage IV With Non-lung Disease Treated With Regimen M
n=50 participants at risk
Stage IV with non-lung disease treated with Regimen M.
|
Stage IV With Lung Metastases
n=23 participants at risk
Stage IV with lung metastases treated with DD4A for less than 6 weeks and/or response inevaluable at week 6.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Bone marrow hypocellular
|
0.00%
0/120
|
0.00%
0/135
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
0.00%
0/23
|
|
Cardiac disorders
Cardiac arrest
|
0.83%
1/120 • Number of events 1
|
0.00%
0/135
|
0.00%
0/52
|
0.00%
0/50
|
0.00%
0/23
|
|
Investigations
Cardiac troponin I increased
|
0.00%
0/120
|
0.00%
0/135
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
0.00%
0/23
|
|
Investigations
CPK increased
|
0.00%
0/120
|
0.00%
0/135
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
0.00%
0/23
|
|
General disorders
Death NOS
|
1.7%
2/120 • Number of events 2
|
2.2%
3/135 • Number of events 3
|
3.8%
2/52 • Number of events 2
|
6.0%
3/50 • Number of events 3
|
0.00%
0/23
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other specify
|
0.00%
0/120
|
0.74%
1/135 • Number of events 1
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
0.00%
0/23
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/120
|
0.00%
0/135
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
0.00%
0/23
|
|
Infections and infestations
Infections and infestations - Other specify
|
0.00%
0/120
|
0.00%
0/135
|
0.00%
0/52
|
4.0%
2/50 • Number of events 2
|
0.00%
0/23
|
|
Gastrointestinal disorders
Intra-abdominal hemorrhage
|
0.00%
0/120
|
0.00%
0/135
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
0.00%
0/23
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign malignant and unspecified (incl cy
|
0.00%
0/120
|
0.74%
1/135 • Number of events 1
|
0.00%
0/52
|
0.00%
0/50
|
0.00%
0/23
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/120
|
0.00%
0/135
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
0.00%
0/23
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/120
|
0.74%
1/135 • Number of events 1
|
0.00%
0/52
|
0.00%
0/50
|
0.00%
0/23
|
|
Investigations
Platelet count decreased
|
0.00%
0/120
|
0.74%
1/135 • Number of events 1
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
0.00%
0/23
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/120
|
0.74%
1/135 • Number of events 1
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
0.00%
0/23
|
|
Injury, poisoning and procedural complications
Postoperative hemorrhage
|
0.00%
0/120
|
0.00%
0/135
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
0.00%
0/23
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/120
|
0.74%
1/135 • Number of events 1
|
0.00%
0/52
|
0.00%
0/50
|
0.00%
0/23
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/120
|
0.00%
0/135
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
0.00%
0/23
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/120
|
0.00%
0/135
|
1.9%
1/52 • Number of events 1
|
0.00%
0/50
|
0.00%
0/23
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory thoracic and mediastinal disorders - Ot
|
0.00%
0/120
|
0.00%
0/135
|
0.00%
0/52
|
2.0%
1/50 • Number of events 2
|
0.00%
0/23
|
|
Infections and infestations
Sepsis
|
0.00%
0/120
|
1.5%
2/135 • Number of events 2
|
0.00%
0/52
|
0.00%
0/50
|
0.00%
0/23
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/120
|
0.74%
1/135 • Number of events 1
|
0.00%
0/52
|
0.00%
0/50
|
0.00%
0/23
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Treatment related secondary malignancy
|
0.00%
0/120
|
0.00%
0/135
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
0.00%
0/23
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
0.00%
0/120
|
0.00%
0/135
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
0.00%
0/23
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/120
|
0.00%
0/135
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
0.00%
0/23
|
|
Investigations
White blood cell decreased
|
0.00%
0/120
|
0.74%
1/135 • Number of events 1
|
0.00%
0/52
|
0.00%
0/50
|
0.00%
0/23
|
Other adverse events
| Measure |
Stage IV and Rapid Complete Response (RCR) of Lung Metastases
n=120 participants at risk
Stage IV and rapid complete response (RCR) of lung metastases continuously treated with DD4A after 6 weeks of DD4A.
|
Stage IV and Slow Incomplete Response (SIR) of Lung Metastases
n=135 participants at risk
Stage IV and slow incomplete response (SIR) of lung metastases treated with Regimen M after 6 weeks of DD4A.
|
Stage III/IV With LOH 1p and 16q Treated With Regimen M
n=52 participants at risk
Stage III/IV with LOH 1p and 16q treated with Regimen M.
|
Stage IV With Non-lung Disease Treated With Regimen M
n=50 participants at risk
Stage IV with non-lung disease treated with Regimen M.
|
Stage IV With Lung Metastases
n=23 participants at risk
Stage IV with lung metastases treated with DD4A for less than 6 weeks and/or response inevaluable at week 6.
|
|---|---|---|---|---|---|
|
Infections and infestations
Abdominal infection
|
0.00%
0/120
|
0.00%
0/135
|
1.9%
1/52 • Number of events 1
|
2.0%
1/50 • Number of events 1
|
0.00%
0/23
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/120
|
0.74%
1/135 • Number of events 1
|
1.9%
1/52 • Number of events 1
|
4.0%
2/50 • Number of events 2
|
0.00%
0/23
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/120
|
1.5%
2/135 • Number of events 2
|
3.8%
2/52 • Number of events 2
|
2.0%
1/50 • Number of events 1
|
0.00%
0/23
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/120
|
0.00%
0/135
|
0.00%
0/52
|
4.0%
2/50 • Number of events 2
|
0.00%
0/23
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/120
|
1.5%
2/135 • Number of events 2
|
0.00%
0/52
|
0.00%
0/50
|
0.00%
0/23
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
0.00%
0/120
|
1.5%
2/135 • Number of events 3
|
0.00%
0/52
|
0.00%
0/50
|
0.00%
0/23
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/120
|
3.7%
5/135 • Number of events 6
|
5.8%
3/52 • Number of events 3
|
12.0%
6/50 • Number of events 6
|
4.3%
1/23 • Number of events 1
|
|
Immune system disorders
Anaphylaxis
|
0.00%
0/120
|
0.74%
1/135 • Number of events 1
|
1.9%
1/52 • Number of events 1
|
0.00%
0/50
|
0.00%
0/23
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/120
|
2.2%
3/135 • Number of events 4
|
3.8%
2/52 • Number of events 2
|
4.0%
2/50 • Number of events 2
|
0.00%
0/23
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/120
|
7.4%
10/135 • Number of events 12
|
9.6%
5/52 • Number of events 7
|
18.0%
9/50 • Number of events 14
|
0.00%
0/23
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/120
|
1.5%
2/135 • Number of events 2
|
3.8%
2/52 • Number of events 2
|
6.0%
3/50 • Number of events 3
|
4.3%
1/23 • Number of events 1
|
|
Infections and infestations
Bladder infection
|
0.00%
0/120
|
0.00%
0/135
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
0.00%
0/23
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other specif
|
0.83%
1/120 • Number of events 1
|
0.00%
0/135
|
0.00%
0/52
|
0.00%
0/50
|
0.00%
0/23
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/120
|
0.00%
0/135
|
0.00%
0/52
|
6.0%
3/50 • Number of events 3
|
0.00%
0/23
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/120
|
0.00%
0/135
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
0.00%
0/23
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
0.00%
0/120
|
0.00%
0/135
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
0.00%
0/23
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/120
|
0.00%
0/135
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
0.00%
0/23
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/120
|
3.0%
4/135 • Number of events 4
|
1.9%
1/52 • Number of events 1
|
4.0%
2/50 • Number of events 2
|
0.00%
0/23
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/120
|
0.74%
1/135 • Number of events 1
|
0.00%
0/52
|
0.00%
0/50
|
0.00%
0/23
|
|
Hepatobiliary disorders
Cholecystitis
|
0.83%
1/120 • Number of events 1
|
0.00%
0/135
|
0.00%
0/52
|
0.00%
0/50
|
0.00%
0/23
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/120
|
1.5%
2/135 • Number of events 2
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
0.00%
0/23
|
|
Investigations
Creatinine increased
|
0.00%
0/120
|
0.74%
1/135 • Number of events 1
|
0.00%
0/52
|
0.00%
0/50
|
0.00%
0/23
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.00%
0/120
|
0.74%
1/135 • Number of events 1
|
0.00%
0/52
|
0.00%
0/50
|
0.00%
0/23
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/120
|
7.4%
10/135 • Number of events 10
|
5.8%
3/52 • Number of events 3
|
2.0%
1/50 • Number of events 1
|
0.00%
0/23
|
|
Psychiatric disorders
Depression
|
0.00%
0/120
|
0.00%
0/135
|
1.9%
1/52 • Number of events 1
|
0.00%
0/50
|
0.00%
0/23
|
|
Infections and infestations
Device related infection
|
0.00%
0/120
|
0.74%
1/135 • Number of events 1
|
0.00%
0/52
|
0.00%
0/50
|
0.00%
0/23
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/120
|
1.5%
2/135 • Number of events 2
|
1.9%
1/52 • Number of events 1
|
4.0%
2/50 • Number of events 2
|
0.00%
0/23
|
|
Infections and infestations
Duodenal infection
|
0.00%
0/120
|
0.74%
1/135 • Number of events 1
|
0.00%
0/52
|
0.00%
0/50
|
0.00%
0/23
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/120
|
0.74%
1/135 • Number of events 1
|
0.00%
0/52
|
4.0%
2/50 • Number of events 2
|
0.00%
0/23
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/120
|
0.00%
0/135
|
1.9%
1/52 • Number of events 1
|
0.00%
0/50
|
0.00%
0/23
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/120
|
0.00%
0/135
|
1.9%
1/52 • Number of events 1
|
2.0%
1/50 • Number of events 1
|
0.00%
0/23
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/120
|
3.0%
4/135 • Number of events 4
|
1.9%
1/52 • Number of events 1
|
2.0%
1/50 • Number of events 1
|
0.00%
0/23
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/120
|
0.74%
1/135 • Number of events 1
|
0.00%
0/52
|
0.00%
0/50
|
0.00%
0/23
|
|
General disorders
Fatigue
|
0.00%
0/120
|
0.74%
1/135 • Number of events 1
|
1.9%
1/52 • Number of events 1
|
0.00%
0/50
|
0.00%
0/23
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/120
|
39.3%
53/135 • Number of events 77
|
40.4%
21/52 • Number of events 27
|
40.0%
20/50 • Number of events 23
|
4.3%
1/23 • Number of events 2
|
|
General disorders
Fever
|
0.00%
0/120
|
3.7%
5/135 • Number of events 6
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
0.00%
0/23
|
|
Gastrointestinal disorders
Gastroparesis
|
0.00%
0/120
|
0.74%
1/135 • Number of events 1
|
0.00%
0/52
|
0.00%
0/50
|
0.00%
0/23
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/120
|
0.74%
1/135 • Number of events 1
|
1.9%
1/52 • Number of events 1
|
0.00%
0/50
|
0.00%
0/23
|
|
Investigations
GGT increased
|
0.00%
0/120
|
1.5%
2/135 • Number of events 2
|
1.9%
1/52 • Number of events 1
|
4.0%
2/50 • Number of events 3
|
0.00%
0/23
|
|
Nervous system disorders
Headache
|
0.00%
0/120
|
0.74%
1/135 • Number of events 1
|
0.00%
0/52
|
0.00%
0/50
|
0.00%
0/23
|
|
Vascular disorders
Hematoma
|
0.00%
0/120
|
0.00%
0/135
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
0.00%
0/23
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/120
|
0.74%
1/135 • Number of events 1
|
1.9%
1/52 • Number of events 1
|
0.00%
0/50
|
0.00%
0/23
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other specify
|
0.00%
0/120
|
0.74%
1/135 • Number of events 1
|
1.9%
1/52 • Number of events 1
|
2.0%
1/50 • Number of events 1
|
0.00%
0/23
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/120
|
0.00%
0/135
|
1.9%
1/52 • Number of events 1
|
0.00%
0/50
|
0.00%
0/23
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.83%
1/120 • Number of events 1
|
2.2%
3/135 • Number of events 3
|
5.8%
3/52 • Number of events 4
|
2.0%
1/50 • Number of events 1
|
0.00%
0/23
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/120
|
0.74%
1/135 • Number of events 1
|
1.9%
1/52 • Number of events 1
|
2.0%
1/50 • Number of events 1
|
0.00%
0/23
|
|
Vascular disorders
Hypertension
|
0.00%
0/120
|
2.2%
3/135 • Number of events 5
|
0.00%
0/52
|
6.0%
3/50 • Number of events 4
|
0.00%
0/23
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/120
|
0.00%
0/135
|
1.9%
1/52 • Number of events 1
|
4.0%
2/50 • Number of events 2
|
0.00%
0/23
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
1.7%
2/120 • Number of events 2
|
0.74%
1/135 • Number of events 1
|
5.8%
3/52 • Number of events 3
|
6.0%
3/50 • Number of events 3
|
0.00%
0/23
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/120
|
4.4%
6/135 • Number of events 6
|
11.5%
6/52 • Number of events 6
|
6.0%
3/50 • Number of events 3
|
0.00%
0/23
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/120
|
2.2%
3/135 • Number of events 3
|
1.9%
1/52 • Number of events 1
|
6.0%
3/50 • Number of events 4
|
0.00%
0/23
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/120
|
0.74%
1/135 • Number of events 1
|
3.8%
2/52 • Number of events 2
|
0.00%
0/50
|
0.00%
0/23
|
|
Vascular disorders
Hypotension
|
0.00%
0/120
|
1.5%
2/135 • Number of events 2
|
3.8%
2/52 • Number of events 2
|
2.0%
1/50 • Number of events 1
|
0.00%
0/23
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/120
|
1.5%
2/135 • Number of events 2
|
0.00%
0/52
|
4.0%
2/50 • Number of events 2
|
0.00%
0/23
|
|
Gastrointestinal disorders
Ileal obstruction
|
0.00%
0/120
|
0.00%
0/135
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
0.00%
0/23
|
|
Gastrointestinal disorders
Ileus
|
1.7%
2/120 • Number of events 2
|
1.5%
2/135 • Number of events 2
|
0.00%
0/52
|
4.0%
2/50 • Number of events 2
|
0.00%
0/23
|
|
Infections and infestations
Infections and infestations - Other specify
|
1.7%
2/120 • Number of events 2
|
14.8%
20/135 • Number of events 22
|
21.2%
11/52 • Number of events 17
|
18.0%
9/50 • Number of events 11
|
0.00%
0/23
|
|
General disorders
Infusion related reaction
|
0.00%
0/120
|
0.74%
1/135 • Number of events 2
|
0.00%
0/52
|
0.00%
0/50
|
0.00%
0/23
|
|
Gastrointestinal disorders
Jejunal obstruction
|
0.00%
0/120
|
0.74%
1/135 • Number of events 1
|
0.00%
0/52
|
0.00%
0/50
|
0.00%
0/23
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
0.00%
0/120
|
0.00%
0/135
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
0.00%
0/23
|
|
Investigations
Lipase increased
|
0.00%
0/120
|
0.00%
0/135
|
0.00%
0/52
|
4.0%
2/50 • Number of events 2
|
0.00%
0/23
|
|
Infections and infestations
Lung infection
|
0.00%
0/120
|
3.0%
4/135 • Number of events 4
|
3.8%
2/52 • Number of events 2
|
2.0%
1/50 • Number of events 1
|
0.00%
0/23
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/120
|
0.00%
0/135
|
0.00%
0/52
|
4.0%
2/50 • Number of events 2
|
0.00%
0/23
|
|
Ear and labyrinth disorders
Middle ear inflammation
|
0.00%
0/120
|
0.00%
0/135
|
1.9%
1/52 • Number of events 1
|
0.00%
0/50
|
0.00%
0/23
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/120
|
0.74%
1/135 • Number of events 1
|
0.00%
0/52
|
0.00%
0/50
|
0.00%
0/23
|
|
Gastrointestinal disorders
Mucositis oral
|
0.83%
1/120 • Number of events 1
|
3.0%
4/135 • Number of events 4
|
3.8%
2/52 • Number of events 2
|
6.0%
3/50 • Number of events 3
|
0.00%
0/23
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/120
|
0.74%
1/135 • Number of events 1
|
0.00%
0/52
|
0.00%
0/50
|
0.00%
0/23
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
0.00%
0/120
|
0.74%
1/135 • Number of events 1
|
0.00%
0/52
|
0.00%
0/50
|
0.00%
0/23
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/120
|
3.7%
5/135 • Number of events 5
|
3.8%
2/52 • Number of events 3
|
8.0%
4/50 • Number of events 4
|
0.00%
0/23
|
|
Investigations
Neutrophil count decreased
|
0.83%
1/120 • Number of events 1
|
3.0%
4/135 • Number of events 6
|
5.8%
3/52 • Number of events 5
|
4.0%
2/50 • Number of events 2
|
0.00%
0/23
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/120
|
0.00%
0/135
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
0.00%
0/23
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/120
|
0.00%
0/135
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
0.00%
0/23
|
|
Infections and infestations
Otitis media
|
0.00%
0/120
|
1.5%
2/135 • Number of events 2
|
3.8%
2/52 • Number of events 2
|
0.00%
0/50
|
0.00%
0/23
|
|
General disorders
Pain
|
0.00%
0/120
|
0.00%
0/135
|
1.9%
1/52 • Number of events 1
|
2.0%
1/50 • Number of events 1
|
0.00%
0/23
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/120
|
0.00%
0/135
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
0.00%
0/23
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/120
|
3.0%
4/135 • Number of events 5
|
5.8%
3/52 • Number of events 4
|
4.0%
2/50 • Number of events 5
|
4.3%
1/23 • Number of events 1
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/120
|
0.74%
1/135 • Number of events 1
|
1.9%
1/52 • Number of events 1
|
2.0%
1/50 • Number of events 2
|
0.00%
0/23
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/120
|
0.00%
0/135
|
1.9%
1/52 • Number of events 1
|
0.00%
0/50
|
0.00%
0/23
|
|
Investigations
Platelet count decreased
|
0.00%
0/120
|
2.2%
3/135 • Number of events 4
|
5.8%
3/52 • Number of events 4
|
4.0%
2/50 • Number of events 2
|
0.00%
0/23
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/120
|
0.00%
0/135
|
1.9%
1/52 • Number of events 1
|
4.0%
2/50 • Number of events 2
|
0.00%
0/23
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/120
|
0.00%
0/135
|
0.00%
0/52
|
4.0%
2/50 • Number of events 2
|
0.00%
0/23
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/120
|
0.00%
0/135
|
1.9%
1/52 • Number of events 1
|
0.00%
0/50
|
0.00%
0/23
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/120
|
0.74%
1/135 • Number of events 1
|
0.00%
0/52
|
0.00%
0/50
|
0.00%
0/23
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/120
|
0.00%
0/135
|
0.00%
0/52
|
4.0%
2/50 • Number of events 2
|
0.00%
0/23
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/120
|
0.00%
0/135
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
0.00%
0/23
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/120
|
0.74%
1/135 • Number of events 1
|
0.00%
0/52
|
0.00%
0/50
|
0.00%
0/23
|
|
Nervous system disorders
Seizure
|
0.00%
0/120
|
1.5%
2/135 • Number of events 2
|
0.00%
0/52
|
0.00%
0/50
|
0.00%
0/23
|
|
Infections and infestations
Sepsis
|
0.00%
0/120
|
2.2%
3/135 • Number of events 3
|
1.9%
1/52 • Number of events 1
|
0.00%
0/50
|
0.00%
0/23
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/120
|
0.00%
0/135
|
0.00%
0/52
|
4.0%
2/50 • Number of events 2
|
0.00%
0/23
|
|
Infections and infestations
Skin infection
|
0.00%
0/120
|
0.74%
1/135 • Number of events 1
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
0.00%
0/23
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/120
|
2.2%
3/135 • Number of events 3
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
0.00%
0/23
|
|
Musculoskeletal and connective tissue disorders
Soft tissue necrosis lower limb
|
0.00%
0/120
|
0.00%
0/135
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
0.00%
0/23
|
|
Infections and infestations
Stoma site infection
|
0.00%
0/120
|
0.74%
1/135 • Number of events 1
|
0.00%
0/52
|
0.00%
0/50
|
0.00%
0/23
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/120
|
0.00%
0/135
|
1.9%
1/52 • Number of events 1
|
0.00%
0/50
|
0.00%
0/23
|
|
Nervous system disorders
Syncope
|
0.00%
0/120
|
0.74%
1/135 • Number of events 1
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
0.00%
0/23
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/120
|
0.00%
0/135
|
0.00%
0/52
|
4.0%
2/50 • Number of events 3
|
0.00%
0/23
|
|
Gastrointestinal disorders
Typhlitis
|
0.00%
0/120
|
1.5%
2/135 • Number of events 2
|
0.00%
0/52
|
0.00%
0/50
|
0.00%
0/23
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/120
|
2.2%
3/135 • Number of events 4
|
3.8%
2/52 • Number of events 3
|
0.00%
0/50
|
0.00%
0/23
|
|
Infections and infestations
Urinary tract infection
|
0.83%
1/120 • Number of events 1
|
2.2%
3/135 • Number of events 3
|
3.8%
2/52 • Number of events 3
|
8.0%
4/50 • Number of events 5
|
0.00%
0/23
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/120
|
1.5%
2/135 • Number of events 2
|
0.00%
0/52
|
2.0%
1/50 • Number of events 2
|
0.00%
0/23
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/120
|
0.74%
1/135 • Number of events 1
|
0.00%
0/52
|
0.00%
0/50
|
0.00%
0/23
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/120
|
0.00%
0/135
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
0.00%
0/23
|
|
Vascular disorders
Vascular disorders - Other specify
|
0.00%
0/120
|
1.5%
2/135 • Number of events 2
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
0.00%
0/23
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/120
|
2.2%
3/135 • Number of events 3
|
5.8%
3/52 • Number of events 3
|
12.0%
6/50 • Number of events 7
|
4.3%
1/23 • Number of events 1
|
|
Infections and infestations
Vulval infection
|
0.00%
0/120
|
0.00%
0/135
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
0.00%
0/23
|
|
Investigations
Weight loss
|
0.00%
0/120
|
0.74%
1/135 • Number of events 1
|
3.8%
2/52 • Number of events 2
|
6.0%
3/50 • Number of events 4
|
0.00%
0/23
|
|
Investigations
White blood cell decreased
|
0.00%
0/120
|
1.5%
2/135 • Number of events 3
|
3.8%
2/52 • Number of events 2
|
2.0%
1/50 • Number of events 1
|
0.00%
0/23
|
|
Infections and infestations
Wound infection
|
0.00%
0/120
|
0.00%
0/135
|
1.9%
1/52 • Number of events 1
|
0.00%
0/50
|
0.00%
0/23
|
Additional Information
Results Reporting Coordinator
Childrens's Oncology Group
Phone: 626-447-0064
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Must obtain prior Sponsor approval.
- Publication restrictions are in place
Restriction type: OTHER