Trial Outcomes & Findings for Combination Chemotherapy and Surgery in Treating Young Patients With Wilms Tumor (NCT NCT00945009)

NCT ID: NCT00945009

Last Updated: 2025-05-31

Results Overview

Probability of no relapse, secondary malignancy, or death whichever occurs first

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE3

Target enrollment

249 participants

Primary outcome timeframe

4 years from study enrollment

Results posted on

2025-05-31

Participant Flow

Participant milestones

Participant milestones
Measure	Arm 1 (Bilateral Wilms Tumors) Patients start with three drug chemotherapy (Regimen VAD; vincristine, dactinomycin and doxorubicin) and are evaluated and six and 12 weeks for feasibility of undergoing a partial nephrectomy/renal sparing surgery. At week 12 definitive surgery takes place followed by chemotherapy and radiation therapy based on histology and stage. Treatment continues for 25 or 31 weeks depending on histology. Patients are followed for up to 10 years following end of therapy. Dactinomycin: Given IV Doxorubicin Hydrochloride: Given IV Radiation Therapy: Undergo radiation therapy Therapeutic Conventional Surgery: Undergo surgical resection Vincristine Sulfate: Given IV	Arm 2 (Unilateral High Risk Tumors Bilaterally Predisposed) Patients start with either 2 drug or three drug chemotherapy (Regimen VA, VAD) and are evaluated a 6 and 12 weeks for feasibility of undergoing a partial nephrectomy. At week 12 definitive surgery takes place followed by chemotherapy. Dactinomycin: Given IV Doxorubicin Hydrochloride: Given IV Radiation Therapy: Undergo radiation therapy Therapeutic Conventional Surgery: Undergo surgical resection Vincristine Sulfate: Given IV	Arm 3 (DHPLN) Patients with this rare disease are diagnosed based on cross-sectional imaging characteristics and undergo 2 drug chemotherapy (Regimen;VA). Patients are reassessed at 6 weeks and 12 weeks. If disease has responded or stayed stable chemotherapy is completed for 19 weeks (Regimen EE4A). If disease has progress a biopsy is performed to assess histology and adjust therapy based on the biopsy. This therapy may include, nephrectomy, chemotherapy or radiation therapy. Dactinomycin: Given IV Doxorubicin Hydrochloride: Given IV Radiation Therapy: Undergo radiation therapy Therapeutic Conventional Surgery: Undergo surgical resection Vincristine Sulfate: Given IV
Overall Study STARTED	201	39	9
Overall Study COMPLETED	156	32	6
Overall Study NOT COMPLETED	45	7	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm 1 (Bilateral Wilms Tumors) Patients start with three drug chemotherapy (Regimen VAD; vincristine, dactinomycin and doxorubicin) and are evaluated and six and 12 weeks for feasibility of undergoing a partial nephrectomy/renal sparing surgery. At week 12 definitive surgery takes place followed by chemotherapy and radiation therapy based on histology and stage. Treatment continues for 25 or 31 weeks depending on histology. Patients are followed for up to 10 years following end of therapy. Dactinomycin: Given IV Doxorubicin Hydrochloride: Given IV Radiation Therapy: Undergo radiation therapy Therapeutic Conventional Surgery: Undergo surgical resection Vincristine Sulfate: Given IV	Arm 2 (Unilateral High Risk Tumors Bilaterally Predisposed) Patients start with either 2 drug or three drug chemotherapy (Regimen VA, VAD) and are evaluated a 6 and 12 weeks for feasibility of undergoing a partial nephrectomy. At week 12 definitive surgery takes place followed by chemotherapy. Dactinomycin: Given IV Doxorubicin Hydrochloride: Given IV Radiation Therapy: Undergo radiation therapy Therapeutic Conventional Surgery: Undergo surgical resection Vincristine Sulfate: Given IV	Arm 3 (DHPLN) Patients with this rare disease are diagnosed based on cross-sectional imaging characteristics and undergo 2 drug chemotherapy (Regimen;VA). Patients are reassessed at 6 weeks and 12 weeks. If disease has responded or stayed stable chemotherapy is completed for 19 weeks (Regimen EE4A). If disease has progress a biopsy is performed to assess histology and adjust therapy based on the biopsy. This therapy may include, nephrectomy, chemotherapy or radiation therapy. Dactinomycin: Given IV Doxorubicin Hydrochloride: Given IV Radiation Therapy: Undergo radiation therapy Therapeutic Conventional Surgery: Undergo surgical resection Vincristine Sulfate: Given IV
Overall Study Lack of Efficacy	10	0	0
Overall Study Physician Decision	21	4	3
Overall Study Protocol Violation	6	1	0
Overall Study Withdrawal by Subject	1	0	0
Overall Study Ineligible	6	1	0
Overall Study Inevaluable	0	1	0
Overall Study Refusal of further protocol	1	0	0

Baseline Characteristics

Combination Chemotherapy and Surgery in Treating Young Patients With Wilms Tumor

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1 (Bilateral Wilms Tumors) n=201 Participants Patients start with three drug chemotherapy (Regimen VAD; vincristine, dactinomycin and doxorubicin) and are evaluated and six and 12 weeks for feasibility of undergoing a partial nephrectomy/renal sparing surgery. At week 12 definitive surgery takes place followed by chemotherapy and radiation therapy based on histology and stage. Treatment continues for 25 or 31 weeks depending on histology. Patients are followed for up to 10 years following end of therapy. Dactinomycin: Given IV Doxorubicin Hydrochloride: Given IV Radiation Therapy: Undergo radiation therapy Therapeutic Conventional Surgery: Undergo surgical resection Vincristine Sulfate: Given IV	Arm 2 (Unilateral High Risk Tumors Bilaterally Predisposed) n=39 Participants Patients start with either 2 drug or three drug chemotherapy (Regimen VA, VAD) and are evaluated a 6 and 12 weeks for feasibility of undergoing a partial nephrectomy. At week 12 definitive surgery takes place followed by chemotherapy. Dactinomycin: Given IV Doxorubicin Hydrochloride: Given IV Radiation Therapy: Undergo radiation therapy Therapeutic Conventional Surgery: Undergo surgical resection Vincristine Sulfate: Given IV	Arm 3 (DHPLN) n=9 Participants Patients with this rare disease are diagnosed based on cross-sectional imaging characteristics and undergo 2 drug chemotherapy (Regimen;VA). Patients are reassessed at 6 weeks and 12 weeks. If disease has responded or stayed stable chemotherapy is completed for 19 weeks (Regimen EE4A). If disease has progress a biopsy is performed to assess histology and adjust therapy based on the biopsy. This therapy may include, nephrectomy, chemotherapy or radiation therapy. Dactinomycin: Given IV Doxorubicin Hydrochloride: Given IV Radiation Therapy: Undergo radiation therapy Therapeutic Conventional Surgery: Undergo surgical resection Vincristine Sulfate: Given IV	Total n=249 Participants Total of all reporting groups
Age, Continuous	32.03 Months STANDARD_DEVIATION 22.22 • n=5 Participants	34.70 Months STANDARD_DEVIATION 22.12 • n=7 Participants	13.26 Months STANDARD_DEVIATION 8.70 • n=5 Participants	31.78 Months STANDARD_DEVIATION 22.12 • n=4 Participants
Sex: Female, Male Female	119 Participants n=5 Participants	23 Participants n=7 Participants	5 Participants n=5 Participants	147 Participants n=4 Participants
Sex: Female, Male Male	82 Participants n=5 Participants	16 Participants n=7 Participants	4 Participants n=5 Participants	102 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	27 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	30 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	168 Participants n=5 Participants	35 Participants n=7 Participants	8 Participants n=5 Participants	211 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	8 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 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
Race (NIH/OMB) Black or African American	31 Participants n=5 Participants	5 Participants n=7 Participants	1 Participants n=5 Participants	37 Participants n=4 Participants
Race (NIH/OMB) White	142 Participants n=5 Participants	29 Participants n=7 Participants	7 Participants n=5 Participants	178 Participants n=4 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
Race (NIH/OMB) Unknown or Not Reported	25 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	29 Participants n=4 Participants

PRIMARY outcome

Timeframe: 4 years from study enrollment

Population: All eligible BWT patients. 6 patients were excluded due to ineligibility and 6 patients were excluded due to protocol violation.

Probability of no relapse, secondary malignancy, or death whichever occurs first

Outcome measures

Outcome measures
Measure	Arm 1 (Bilateral Wilms Tumors) n=189 Participants Patients start with three drug chemotherapy (Regimen VAD; vincristine, dactinomycin and doxorubicin) and are evaluated and six and 12 weeks for feasibility of undergoing a partial nephrectomy/renal sparing surgery. At week 12 definitive surgery takes place followed by chemotherapy and radiation therapy based on histology and stage. Treatment continues for 25 or 31 weeks depending on histology. Patients are followed for up to 10 years following end of therapy. Dactinomycin: Given IV Doxorubicin Hydrochloride: Given IV Radiation Therapy: Undergo radiation therapy Therapeutic Conventional Surgery: Undergo surgical resection Vincristine Sulfate: Given IV
Event-Free Survival (EFS)	0.82 Probability Interval 0.74 to 0.91

PRIMARY outcome

Timeframe: 12 weeks from study entry

Population: Eligible and evaluable Bilateral Wilms Tumor patients who completed pre-nephrectomy chemotherapy (VAD). 49 patients who did not complete VAD were excluded.

Prevention of complete removal of at least one kidney in 50% of patients with bilateral Wilms tumor (BWT).

Outcome measures

Outcome measures
Measure	Arm 1 (Bilateral Wilms Tumors) n=140 Participants Patients start with three drug chemotherapy (Regimen VAD; vincristine, dactinomycin and doxorubicin) and are evaluated and six and 12 weeks for feasibility of undergoing a partial nephrectomy/renal sparing surgery. At week 12 definitive surgery takes place followed by chemotherapy and radiation therapy based on histology and stage. Treatment continues for 25 or 31 weeks depending on histology. Patients are followed for up to 10 years following end of therapy. Dactinomycin: Given IV Doxorubicin Hydrochloride: Given IV Radiation Therapy: Undergo radiation therapy Therapeutic Conventional Surgery: Undergo surgical resection Vincristine Sulfate: Given IV
Kidney Preservation After Preoperative Chemotherapy	39 Percentage of patients Interval 31.0 to 47.0

PRIMARY outcome

Timeframe: 12 weeks from the study entry

Population: Eligible and evaluable patients with diffuse hyperplastic perilobar nephroblastomatosis (DPHLN).

To evaluate the efficacy of chemotherapy in preserving renal units in children with diffuse hyperplastic perilobar nephroblastomatosis (DHPLN) and preventing Wilms tumor development.

Outcome measures

Outcome measures
Measure	Arm 1 (Bilateral Wilms Tumors) n=9 Participants Patients start with three drug chemotherapy (Regimen VAD; vincristine, dactinomycin and doxorubicin) and are evaluated and six and 12 weeks for feasibility of undergoing a partial nephrectomy/renal sparing surgery. At week 12 definitive surgery takes place followed by chemotherapy and radiation therapy based on histology and stage. Treatment continues for 25 or 31 weeks depending on histology. Patients are followed for up to 10 years following end of therapy. Dactinomycin: Given IV Doxorubicin Hydrochloride: Given IV Radiation Therapy: Undergo radiation therapy Therapeutic Conventional Surgery: Undergo surgical resection Vincristine Sulfate: Given IV
Number of Patients Without Complete Removal of at Least One Kidney	7 Participants

PRIMARY outcome

Timeframe: 12 weeks from study entry

Population: Eligible and evaluable patients with unilateral high risk tumors who had partial or complete nephrectomy. 16 total patients were excluded (1 ineligible, 1 inevaluable, 1 violated protocol, and 13 did not have definitive surgery (partial or complete nephrectomy).

Percentage of patients who experienced partial nephrectomy in lieu of nephrectomy in 25% of children with unilateral tumors and aniridia, Beckwith-Wiedemann syndrome (BWS), hemihypertrophy or other overgrowth syndromes, by using prenephrectomy 2-drug chemotherapy induction with vincristine and dactinomycin.

Outcome measures

Outcome measures
Measure	Arm 1 (Bilateral Wilms Tumors) n=23 Participants Patients start with three drug chemotherapy (Regimen VAD; vincristine, dactinomycin and doxorubicin) and are evaluated and six and 12 weeks for feasibility of undergoing a partial nephrectomy/renal sparing surgery. At week 12 definitive surgery takes place followed by chemotherapy and radiation therapy based on histology and stage. Treatment continues for 25 or 31 weeks depending on histology. Patients are followed for up to 10 years following end of therapy. Dactinomycin: Given IV Doxorubicin Hydrochloride: Given IV Radiation Therapy: Undergo radiation therapy Therapeutic Conventional Surgery: Undergo surgical resection Vincristine Sulfate: Given IV
Percentage of Patients Who Experienced Partial Nephrectomy After Preoperative Chemotherapy	57 percentage of patients Interval 37.0 to 77.0

PRIMARY outcome

Timeframe: 12 weeks from study entry

Population: Eligible and evaluable Bilateral Wilms Tumor patients. 6 patients were excluded due to ineligible and 6 patients were excluded due to protocol violation.

Percentage of Bilateral Wilms Tumor (BWT) patients who undergo definitive surgery by week 12 after initiation of chemotherapy.

Outcome measures

Outcome measures
Measure	Arm 1 (Bilateral Wilms Tumors) n=189 Participants Patients start with three drug chemotherapy (Regimen VAD; vincristine, dactinomycin and doxorubicin) and are evaluated and six and 12 weeks for feasibility of undergoing a partial nephrectomy/renal sparing surgery. At week 12 definitive surgery takes place followed by chemotherapy and radiation therapy based on histology and stage. Treatment continues for 25 or 31 weeks depending on histology. Patients are followed for up to 10 years following end of therapy. Dactinomycin: Given IV Doxorubicin Hydrochloride: Given IV Radiation Therapy: Undergo radiation therapy Therapeutic Conventional Surgery: Undergo surgical resection Vincristine Sulfate: Given IV
Percentage of Patients Who Had Definitive Surgical Treatment	85 percentage of participants Interval 80.0 to 90.0

Adverse Events

Arm 1 (Bilateral Wilms Tumors)

Serious events: 12 serious events

Other events: 34 other events

Deaths: 10 deaths

Arm 2 (Unilateral High Risk Tumors Bilaterally Predisposed)

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Arm 3 (DHPLN)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm 1 (Bilateral Wilms Tumors) n=189 participants at risk Patients start with three drug chemotherapy (Regimen VAD; vincristine, dactinomycin and doxorubicin) and are evaluated and six and 12 weeks for feasibility of undergoing a partial nephrectomy/renal sparing surgery. At week 12 definitive surgery takes place followed by chemotherapy and radiation therapy based on histology and stage. Treatment continues for 25 or 31 weeks depending on histology. Patients are followed for up to 10 years following end of therapy. Dactinomycin: Given IV Doxorubicin Hydrochloride: Given IV Radiation Therapy: Undergo radiation therapy Therapeutic Conventional Surgery: Undergo surgical resection Vincristine Sulfate: Given IV	Arm 2 (Unilateral High Risk Tumors Bilaterally Predisposed) n=36 participants at risk Patients start with either 2 drug or three drug chemotherapy (Regimen VA, VAD) and are evaluated a 6 and 12 weeks for feasibility of undergoing a partial nephrectomy. At week 12 definitive surgery takes place followed by chemotherapy. Dactinomycin: Given IV Doxorubicin Hydrochloride: Given IV Radiation Therapy: Undergo radiation therapy Therapeutic Conventional Surgery: Undergo surgical resection Vincristine Sulfate: Given IV	Arm 3 (DHPLN) n=9 participants at risk Patients with this rare disease are diagnosed based on cross-sectional imaging characteristics and undergo 2 drug chemotherapy (Regimen;VA). Patients are reassessed at 6 weeks and 12 weeks. If disease has responded or stayed stable chemotherapy is completed for 19 weeks (Regimen EE4A). If disease has progress a biopsy is performed to assess histology and adjust therapy based on the biopsy. This therapy may include, nephrectomy, chemotherapy or radiation therapy. Dactinomycin: Given IV Doxorubicin Hydrochloride: Given IV Radiation Therapy: Undergo radiation therapy Therapeutic Conventional Surgery: Undergo surgical resection Vincristine Sulfate: Given IV
Investigations 11600-Alanine aminotransferase increased	0.53% 1/189 • Number of events 1 • From enrollment to up to 10 years of follow-up Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/36 • From enrollment to up to 10 years of follow-up Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/9 • From enrollment to up to 10 years of follow-up Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
Investigations 15000-Aspartate aminotransferase increased	0.53% 1/189 • Number of events 1 • From enrollment to up to 10 years of follow-up Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/36 • From enrollment to up to 10 years of follow-up Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/9 • From enrollment to up to 10 years of follow-up Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
General disorders 24600-Death NOS	4.2% 8/189 • Number of events 8 • From enrollment to up to 10 years of follow-up Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/36 • From enrollment to up to 10 years of follow-up Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/9 • From enrollment to up to 10 years of follow-up Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
Hepatobiliary disorders 40600-Hepatobiliary disorders - Other specify	1.6% 3/189 • Number of events 3 • From enrollment to up to 10 years of follow-up Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.	2.8% 1/36 • Number of events 1 • From enrollment to up to 10 years of follow-up Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/9 • From enrollment to up to 10 years of follow-up Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
Metabolism and nutrition disorders 43100-Hypokalemia	0.53% 1/189 • Number of events 1 • From enrollment to up to 10 years of follow-up Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/36 • From enrollment to up to 10 years of follow-up Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/9 • From enrollment to up to 10 years of follow-up Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
Respiratory, thoracic and mediastinal disorders 71500-Respiratory failure	0.53% 1/189 • Number of events 1 • From enrollment to up to 10 years of follow-up Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/36 • From enrollment to up to 10 years of follow-up Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/9 • From enrollment to up to 10 years of follow-up Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
Investigations 83600-Urine output decreased	0.53% 1/189 • Number of events 1 • From enrollment to up to 10 years of follow-up Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/36 • From enrollment to up to 10 years of follow-up Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/9 • From enrollment to up to 10 years of follow-up Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.

Other adverse events

Additional Information

Results Reporting Coordinator

Children's Oncology Group

Phone: 626-447-0064

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place