NCT00945009 · ADVERSE EVENTS

Adverse events

Combination Chemotherapy and Surgery in Treating Young Patients With Wilms Tumor · Source last updated 2026-06-03

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: From enrollment to up to 10 years of follow-up
Other-event reporting threshold: 0%

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.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
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	12 / 189	34 / 189	10 / 189
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	1 / 36	1 / 36	0 / 36
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	0 / 9	0 / 9	0 / 9

Group identifiers: EG000: Arm 1 (Bilateral Wilms Tumors) · EG001: Arm 2 (Unilateral High Risk Tumors Bilaterally Predisposed) · EG002: Arm 3 (DHPLN)

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
1
num At Risk
189
num Events
1
group Id
EG001
num Affected
0
num At Risk
36
num Events
0
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
term
11600-Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
1
num At Risk
189
num Events
1
group Id
EG001
num Affected
0
num At Risk
36
num Events
0
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
term
15000-Aspartate aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
8
num At Risk
189
num Events
8
group Id
EG001
num Affected
0
num At Risk
36
num Events
0
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
term
24600-Death NOS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
3
num At Risk
189
num Events
3
group Id
EG001
num Affected
1
num At Risk
36
num Events
1
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
term
40600-Hepatobiliary disorders - Other specify
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
1
num At Risk
189
num Events
1
group Id
EG001
num Affected
0
num At Risk
36
num Events
0
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
term
43100-Hypokalemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
1
num At Risk
189
num Events
1
group Id
EG001
num Affected
0
num At Risk
36
num Events
0
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
term
71500-Respiratory failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
1
num At Risk
189
num Events
1
group Id
EG001
num Affected
0
num At Risk
36
num Events
0
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
term
83600-Urine output decreased

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
1
num At Risk
189
num Events
1
group Id
EG001
num Affected
0
num At Risk
36
num Events
0
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
term
10300-Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
1
num At Risk
189
num Events
1
group Id
EG001
num Affected
0
num At Risk
36
num Events
0
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
term
10700-Acidosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
3
num At Risk
189
num Events
3
group Id
EG001
num Affected
0
num At Risk
36
num Events
0
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
term
11100-Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
1
num At Risk
189
num Events
1
group Id
EG001
num Affected
1
num At Risk
36
num Events
2
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
term
11600-Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
1
num At Risk
189
num Events
1
group Id
EG001
num Affected
0
num At Risk
36
num Events
0
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
term
11900-Alkalosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
1
num At Risk
189
num Events
1
group Id
EG001
num Affected
0
num At Risk
36
num Events
0
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
term
13200-Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
1
num At Risk
189
num Events
1
group Id
EG001
num Affected
0
num At Risk
36
num Events
0
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
term
14000-Aphonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
1
num At Risk
189
num Events
1
group Id
EG001
num Affected
0
num At Risk
36
num Events
0
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
term
14100-Apnea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
2
num At Risk
189
num Events
2
group Id
EG001
num Affected
1
num At Risk
36
num Events
2
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
term
15000-Aspartate aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
1
num At Risk
189
num Events
1
group Id
EG001
num Affected
0
num At Risk
36
num Events
0
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
term
15400-Atelectasis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
1
num At Risk
189
num Events
1
group Id
EG001
num Affected
0
num At Risk
36
num Events
0
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
term
18800-Bronchial infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
1
num At Risk
189
num Events
1
group Id
EG001
num Affected
0
num At Risk
36
num Events
0
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
term
20100-Cardiac disorders - Other specify

Complete source fields

description

event Groups

deaths Num Affected
10
deaths Num At Risk
189
description
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
id
EG000
other Num Affected
34
other Num At Risk
189
serious Num Affected
12
serious Num At Risk
189
title
Arm 1 (Bilateral Wilms Tumors)
deaths Num Affected
0
deaths Num At Risk
36
description
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
id
EG001
other Num Affected
1
other Num At Risk
36
serious Num Affected
1
serious Num At Risk
36
title
Arm 2 (Unilateral High Risk Tumors Bilaterally Predisposed)
deaths Num Affected
0
deaths Num At Risk
9
description
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
id
EG002
other Num Affected
0
other Num At Risk
9
serious Num Affected
0
serious Num At Risk
9
title
Arm 3 (DHPLN)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
1
num At Risk
189
num Events
1
group Id
EG001
num Affected
0
num At Risk
36
num Events
0
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
term
10300-Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
1
num At Risk
189
num Events
1
group Id
EG001
num Affected
0
num At Risk
36
num Events
0
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
term
10700-Acidosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
3
num At Risk
189
num Events
3
group Id
EG001
num Affected
0
num At Risk
36
num Events
0
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
term
11100-Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
1
num At Risk
189
num Events
1
group Id
EG001
num Affected
1
num At Risk
36
num Events
2
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
term
11600-Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
1
num At Risk
189
num Events
1
group Id
EG001
num Affected
0
num At Risk
36
num Events
0
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
term
11900-Alkalosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
1
num At Risk
189
num Events
1
group Id
EG001
num Affected
0
num At Risk
36
num Events
0
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
term
13200-Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
1
num At Risk
189
num Events
1
group Id
EG001
num Affected
0
num At Risk
36
num Events
0
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
term
14000-Aphonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
1
num At Risk
189
num Events
1
group Id
EG001
num Affected
0
num At Risk
36
num Events
0
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
term
14100-Apnea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
2
num At Risk
189
num Events
2
group Id
EG001
num Affected
1
num At Risk
36
num Events
2
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
term
15000-Aspartate aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
1
num At Risk
189
num Events
1
group Id
EG001
num Affected
0
num At Risk
36
num Events
0
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
term
15400-Atelectasis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
1
num At Risk
189
num Events
1
group Id
EG001
num Affected
0
num At Risk
36
num Events
0
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
term
18800-Bronchial infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
1
num At Risk
189
num Events
1
group Id
EG001
num Affected
0
num At Risk
36
num Events
0
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
term
20100-Cardiac disorders - Other specify

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
1
num At Risk
189
num Events
1
group Id
EG001
num Affected
0
num At Risk
36
num Events
0
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
term
11600-Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
1
num At Risk
189
num Events
1
group Id
EG001
num Affected
0
num At Risk
36
num Events
0
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
term
15000-Aspartate aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
8
num At Risk
189
num Events
8
group Id
EG001
num Affected
0
num At Risk
36
num Events
0
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
term
24600-Death NOS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
3
num At Risk
189
num Events
3
group Id
EG001
num Affected
1
num At Risk
36
num Events
1
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
term
40600-Hepatobiliary disorders - Other specify
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
1
num At Risk
189
num Events
1
group Id
EG001
num Affected
0
num At Risk
36
num Events
0
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
term
43100-Hypokalemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
1
num At Risk
189
num Events
1
group Id
EG001
num Affected
0
num At Risk
36
num Events
0
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
term
71500-Respiratory failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
1
num At Risk
189
num Events
1
group Id
EG001
num Affected
0
num At Risk
36
num Events
0
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
term
83600-Urine output decreased

time Frame

From enrollment to up to 10 years of follow-up

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice